Infusion Pump is a medical device that precisely delivers fluids, medications (like insulin, chemo, antibiotics), nutrients, or blood directly into a patient’s body at controlled rates, preventing manual errors for critical care, hydration, or feeding, via IV, subcutaneous, or other routes, with types including bedside, portable, and specialized pumps for different volumes and needs.

Intended Use of Infusion Pump

The Infusion Pump is intended to deliver fluids, medications, nutrients, or blood products into a patient’s body in a controlled and programmable manner. It is designed for use by trained healthcare professionals or caregivers in hospitals, clinical, or home healthcare settings, depending on the device configuration.

Intended Use:

An Infusion Pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically.it is operated using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm

Device Description:

It is an electrically powered medical device used to deliver fluids, medicines, nutrients, or blood into a patient’s body in a controlled and accurate way.  it can deliver therapy through intravenous, subcutaneous, enteral, or epidural routes. It includes a reusable pump and disposable tubing sets. It can control how much fluid is delivered and at what rate, based on settings entered by the user. It has a display and controls to program infusion details and provides sound and visual alerts for issues such as blockages, air in the line, low battery, or completion of the infusion. It can operate using main power or an internal battery, allowing use during patient movement or power interruptions. It includes built-in safety features to ensure accurate delivery and prevent dosing errors. It is intended for use in hospitals, clinical, or home settings, with sterile, single-use disposable sets and a non-sterile reusable pump unit.

Controller, Infusion, Intravascular, Electronic

Intended Use:

The Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by trained healthcare professionals.

Device Description:

 It is an electronically operated medical device designed to control and maintain the flow rate of intravenous fluids delivered to adult patients using a gravity infusion system in a clinical setting. It is used by trained healthcare professionals for the administration of general maintenance fluids and non-critical antibiotics. It works by regulating fluid flow through compatible IV tubing connected to a gravity-fed fluid source and allows the user to set and monitor the prescribed infusion rate. The controller includes basic monitoring and alarm features to alert the user to interruptions or abnormal conditions during infusion. The device does not directly contact the patient, as all patient-contacting components are provided through separate sterile infusion sets.

Warmer, Thermal, Infusion Fluid

Intended Use:

The infusion fluid warmer is intended to warm intravenous fluids, blood, and blood products prior to or during administration to patients in clinical settings, in order to help prevent hypothermia during medical and surgical procedures. It is used by trained healthcare professionals.

Device Description:

It is an electrically powered medical device designed to warm intravenous fluids, blood, and blood products prior to or during patient administration. It consists of a main control unit, an internal heating element, a temperature sensing and control system, and a fluid pathway interface compatible with standard IV tubing or disposable warming sets. It continuously monitors and regulates fluid temperature to maintain a safe warming range and includes safety features such as over-temperature protection and visual or audible alarms. It is intended for use in clinical environments by trained healthcare professionals and does not come into direct contact with the patient.

Warmer, Microwave, Infusion Fluid

Intended Use:

The Microwave Infusion Fluid Warmer is intended to warm infusion fluids such as intravenous solutions to a controlled temperature prior to administration to patients. It is designed to reduce the risk of hypothermia associated with the administration of cold infusion fluids. It is intended for use in healthcare settings by trained medical personnel.

Device Description:

 It is an electrically powered medical device that uses microwave energy to uniformly heat infusion fluid containers under controlled conditions. It consists of a microwave heating chamber, temperature control system, user interface, and safety features to prevent overheating. Infusion fluid containers are placed inside the chamber, and the device warms the fluid to a predefined temperature range suitable for clinical use. It is intended for use with compatible infusion fluid containers and operates in accordance with specified operating parameters to ensure safe and effective warming of fluids prior to infusion.

Pump, Infusion, Analytical Sampling

Intended Use:

The Infusion Pump for Analytical Sampling is intended to deliver precise volumes of fluids, including medications, solutions, or analytes, to a patient or system in a controlled manner. It may also be used to collect samples for analytical or laboratory testing in research or clinical settings. The device is intended for use by trained healthcare professionals or laboratory personnel in hospitals, clinics, or laboratory environments.

Device Description:

It is an electrically powered medical device designed to accurately control the delivery and withdrawal of fluids for infusion and analytical sampling purposes. It incorporates a controlled pumping mechanism, such as a peristaltic or syringe-based system, governed by an electronic control unit that regulates flow rate, volume, and timing. A user interface allows operators to set parameters and monitor operation, while integrated safety features such as occlusion detection, air-in-line detection, and alarm systems help ensure safe and reliable performance. It is intended to maintain fluid integrity and accuracy during infusion or sampling and does not alter the composition of the fluids. It is suitable for use in clinical or laboratory environments by trained personnel.

Insulin Infusion Pump

Intended Use:

The Insulin Infusion Pump is intended for the continuous subcutaneous delivery of insulin at programmable rates for the management of diabetes mellitus. It is designed to deliver precise and controlled doses of insulin to maintain glycemic control and reduce fluctuations in blood glucose levels. It is intended for use by patients or trained caregivers under the supervision of a healthcare professional in home or clinical settings.

Device Description:

The Insulin Infusion Pump is a portable, electrically powered medical device designed to deliver insulin through a controlled pumping mechanism at preset basal rates and user-initiated bolus doses. It consists of a pump unit, insulin reservoir, infusion set with subcutaneous cannula, electronic control system, and user interface for programming and monitoring delivery parameters. Integrated safety features such as occlusion detection, delivery alarms, and system status indicators are provided to support safe operation. The pump delivers insulin continuously through the infusion set and is designed to ensure accurate, reliable, and consistent insulin administration without altering the insulin formulation.

Pump, Infusion, Enteral

Intended Use:

Enteral Feeding Pump System is intended to be used by healthcare professionals, patients and caregivers for the intermittent and continuous delivery of enteral fluids for adult and pediatric (infant, child, and adolescent) feeding therapy in hospital and home care environments.

Device Descriptions:

Enteral Feeding Pump System is comprised of an enteral infusion pump and disposable. Pump is a rotary peristaltic pump engineered to deliver doses of enteral fluids at selectable rates programmed with a newly designed purpose- specific touchscreen interface. The pump body is designed to be ergonomic and portable. Feed Sets are non-sterile, single patients use enteral feed sets that are designed to be anti-free flow until the pump is running. The feed sets are designed with cassettes for the simple loading and unloading of the feed set without a pump door.

Pump, Infusion, Elastomeric

Intended Use:

The Elastomeric Infusion Pump is intended for the controlled, continuous delivery of prescribed liquid medications, such as analgesics, antibiotics, chemotherapy agents, or other therapeutic fluids, to adult patients in a clinical, ambulatory, or home care setting. It delivers medication at a pre-set flow rate using elastomeric pressure and does not require external power. It is intended to be used by trained healthcare professionals or patients/caregivers under the supervision and instruction of a healthcare provider.

Device Description:

The Elastomeric Infusion Pump is a single-use, disposable infusion device that provides controlled drug delivery through a self-expanding elastomeric reservoir. It consists of an elastomeric balloon reservoir enclosed within a protective housing, a fill port with one-way valve, a flow restrictor to regulate the infusion rate, and an administration set with tubing and a patient connector compatible with standard intravenous or subcutaneous access devices. When filled, the elastomeric reservoir generates pressure that drives the medication through the flow restrictor and tubing to the patient at a predetermined rate. The pump contains no electronic components or batteries and is designed for portability, ease of use, and reliable continuous infusion over a specified duration

Pump, Infusion, Ophthalmic

Intended Use:

The ophthalmic infusion pump is intended to deliver a controlled and continuous flow of sterile ophthalmic irrigation or infusion fluids during ophthalmic surgical procedures. It is used to maintain intraocular pressure, chamber stability, and a clear surgical field while supporting surgical manipulation of ocular tissues. It is intended for use in a clinical or surgical setting by trained ophthalmic healthcare professionals.

Device Description:

The ophthalmic infusion pump is an electrically powered infusion device designed to precisely regulate the flow rate and pressure of ophthalmic fluids. It typically consists of a pump unit with a control interface, pressure and flow sensors, a disposable sterile tubing set, and connectors compatible with standard ophthalmic cannulas. It allows adjustment and monitoring of infusion parameters to ensure accurate fluid delivery and safe operation during ophthalmic procedures.

Accessories, Pump, Infusion

Intended Use:

 The infusion pump accessories are intended for use in conjunction with a compatible infusion pump to support the controlled delivery of fluids, medications, or irrigation solutions to patients in a clinical setting. These accessories enable proper connection, regulation, and monitoring of fluid flow during infusion therapy and are intended for use by trained healthcare professionals.

Device Description:

 Infusion pump accessories include sterile and non-sterile components such as infusion tubing sets, extension lines, connectors, clamps, filters, pressure sensors, and mounting or securing devices. These accessories are designed to interface with the infusion pump and fluid containers to ensure accurate, safe, and reliable fluid delivery. They are manufactured from biocompatible materials and may be single-use or reusable, depending on the specific accessory and intended clinical application.

Pump, Infusion, Insulin Bolus

Intended Use:

The insulin bolus infusion pump is intended to deliver a programmed bolus dose of insulin for the management of diabetes mellitus. It provides precise, controlled administration of insulin to help regulate blood glucose levels and is intended for use in clinical or home-care settings by trained healthcare professionals or patients who have been appropriately trained in its use

Device Description:

The Insulin Bolus Infusion Pump is a portable, electrically powered infusion device designed to deliver accurate bolus doses of insulin. It consists of a pump unit with a user interface for dose programming, an insulin reservoir or cartridge, a pumping mechanism, delivery tubing, and a subcutaneous infusion set. It includes safety features such as dose limits, alarms, and occlusion detection to support reliable insulin delivery during bolus administration.

Infusion Safety Management Software

Intended Use:

Infusion Safety Management Software is intended to support the safe administration of intravenous fluids and medications by monitoring, analyzing, and managing infusion-related data from compatible infusion devices. The software is designed to assist healthcare professionals by identifying potential infusion risks, generating alerts, and supporting compliance with institutional infusion protocols in clinical care settings.

Device Description:

 Infusion Safety Management Software is a medical device software system that interfaces with compatible infusion pumps and related hospital information systems. The software collects and processes infusion parameters such as flow rate, volume, drug library data, alarms, and user actions. It provides features including real-time monitoring, dose error reduction support, alert management, reporting, and trend analysis to enhance infusion safety and quality assurance. The system may be deployed as a standalone application or as a networked platform hosted on local servers or secure cloud infrastructure and includes user access controls, data integrity safeguards, and cybersecurity protections

Immunoglobulin G (Igg) Infusion System

Intended Use:

The Immunoglobulin G (IgG) Infusion System is intended for the controlled administration of Immunoglobulin G (IgG) solutions to patients as prescribed by a healthcare professional. The system is designed for intravenous or subcutaneous infusion of IgG at specified flow rates and volumes in clinical and/or home care settings under appropriate medical supervision.

Device Description:

The Immunoglobulin G (IgG) Infusion System is a powered infusion system designed for use with approved IgG drug products and compatible administration sets. It consists of an infusion pump, disposable infusion tubing, and a user interface for setting infusion parameters. It includes safety features such as flow rate control, occlusion detection, air-in-line detection, end-of-infusion alerts, and system alarms to support accurate and reliable delivery. It does not alter the drug formulation and is intended to deliver IgG solutions supplied in standard containers as provided by the manufacturer or pharmacy.

Peripheral Intravenous (Piv) Infiltration Monitor

Intended Use:

The Peripheral Intravenous (PIV) Infiltration Monitor is intended to continuously monitor peripheral intravenous access sites for indications of infiltration or extravasation during intravenous fluid or medication administration. It is designed to provide an alert to healthcare professionals when changes at the infusion site suggest possible infiltration, enabling timely clinical intervention in hospital and other clinical care settings.

Device Description:

The Peripheral Intravenous (PIV) Infiltration Monitor is a non-invasive monitoring system that is applied at or near a peripheral IV insertion site and operates in conjunction with standard infusion therapy. It consists of sensors, a monitoring unit, and a user notification system. It detects physiological or physical changes associated with infiltration, such as variations in tissue impedance, pressure, temperature, or fluid accumulation, and generates alarms when preset thresholds are exceeded. The monitor does not deliver fluids or medications and is intended to supplement, not replace, routine clinical assessment of peripheral IV sites.

Infusion Pump, Drug Specific, Pharmacy-Filled

Intended Use:

The Drug-Specific, Pharmacy-Filled Infusion Pump is intended for the controlled delivery of a single, pre-specified liquid medication that is prefilled by the pharmacy into a dedicated drug reservoir or cartridge. The device is designed to administer the medication to patients at a prescribed flow rate and volume through an infusion set, in clinical or non-clinical care settings, under the supervision of trained healthcare professionals or as prescribed for patient use.

Device Description:

 The Drug-Specific, Pharmacy-Filled Infusion Pump is a programmable or preset infusion system designed for use with a specific drug formulation and a compatible, pharmacy-prefilled container. It consists of a pumping mechanism, control electronics, power source, user interface, and alarms for occlusion, end-of-infusion, and system faults. It delivers medication via a disposable infusion set and restricts use of the intended drug to reduce medication errors. It include safety features such as flow rate limits, lockout mechanisms, and drug-specific identification to ensure accurate and reliable drug delivery.

Alternate Controller Enabled Insulin Infusion Pump

Intended Use:

An Alternate Controller Enabled Infusion Pump (ACE pump) is a device intended for the infusion of drugs into a patient. It includes basal and bolus drug delivery at set or variable rates.  pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. It intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery

Device Description:

The Alternate Controller Enabled (ACE) Insulin Infusion Pump is a small wearable device that delivers insulin continuously under the skin to help manage diabetes. It uses an insulin reservoir and infusion set to provide preset basal insulin and user-initiated bolus doses. It is controlled wirelessly through a compatible external controller, such as a mobile app, which allows users to adjust insulin delivery settings. It includes safety features like alarms for blockages, low battery, or empty insulin, and can be used with compatible glucose monitoring systems through the controller.

Hemodialysis System And Accessories

Intended Use:

A Hemodialysis System And Accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flow through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semi-permeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semi-permeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Device Description:

The device is a medical infusion pump or syringe pump designed to deliver fluids, medications, or nutrients into a patient’s body in a controlled and accurate way using an extra-luminal tubing system. It consists of a reusable pump unit that controls the flow and a disposable tubing set or syringe that connects to the patient. It allows users to program delivery rates, volumes, and schedules, and it provides alarms or alerts for issues like blockages, low fluid, or system errors. The device can operate on battery or main power, allowing use in hospitals, clinics, or home care settings. Safety features ensure accurate delivery and reduce the risk of dosing errors.

Performance Testing for Infusion Pump

• Flow rate accuracy
• Volume delivery accuracy
• Occlusion detection and response time
• Air-in-line detection (if applicable)
• Start-up, stop, and alarm functionality
• Battery performance and backup operation
• Long-term reliability / endurance testing
• Mechanical strength and durability
• Drop, vibration, and shock testing
• Environmental testing (temperature, humidity, altitude)
• Electrical Safety & EMC Testing
• Software & Cybersecurity Testing
• Usability & Human Factors Testing
• Biocompatibility Testing (e.g., cytotoxicity, sensitization, irritation)
• Packaging & Sterilization Testing (disposables)

Clinical Testing for Infusion Pump

No Guidance available for 510k submission