Ventilators are medical devices intended to provide mechanical ventilation by assisting or replacing spontaneous breathing in patients who are unable to breathe adequately on their own. These devices are used in critical care, emergency, surgical, and transport settings, and are considered life-supporting medical devices under U.S. FDA regulations.

Intended Use of Ventilators

Ventilators are intended to provide continuous or intermittent ventilatory support for patients requiring respiratory assistance due to conditions such as respiratory failure, anaesthesia, trauma, or neuromuscular disorders. These devices support oxygen delivery, carbon dioxide removal, and airway pressure regulation in adult, pediatric, and neonatal patient populations, depending on the device design and indications for use.

Ventilators are used in:

• Hospital and intensive care unit (ICU)
• Emergency and transport ventilation
• Facility-based or prescribed home-use ventilation

Intended Use: Powered Emergency Ventilators are intended to provide short-term respiratory support in emergency or urgent care settings. These devices deliver positive pressure ventilation to patients who are apneic or in respiratory failure during emergency response, resuscitation, or transport until definitive airway management can be established.

Device Description: A Powered Emergency Ventilator is a compact, mechanically driven device that delivers controlled breaths at preset pressures or volumes. It generally includes a power source (battery or mains), pressure/flow control mechanisms, safety alarms, and basic monitoring. The device is designed for immediate deployment by trained healthcare personnel in hospitals, ambulances, or field settings.

Ventilator, Emergency, Manual (Resuscitator)

Intended Use: Manual Emergency Ventilators are intended to provide temporary respiratory support in emergency situations where mechanical ventilation is unavailable or until advanced airway management is provided.

Device Description: A Manual Emergency Ventilator typically consists of a hand-operated resuscitation bag or similar device that delivers positive pressure breaths when squeezed. It includes a patient interface (mask or tube connector) and may include pressure relief valves to prevent barotrauma. These devices are portable and used by trained responders in emergency departments, ambulances, or pre-hospital environments.

Ventilator, External Body, Negative Pressure

Intended Use: External Negative Pressure Ventilators are intended to support breathing by alternating negative pressure around the thorax and abdomen to stimulate inhalation and exhalation in patients with respiratory insufficiency.

Device Description: An External Negative Pressure Ventilator is a non-invasive ventilatory support system that surrounds the patient’s body (e.g., iron lung or cuirass device) and applies cyclic negative pressures to assist ventilation. It is designed for adult patients and may be used in institutional or chronic care settings when positive pressure ventilation is contraindicated or not tolerated.

Ventilator, Non-Continuous (Respirator, IPPB)

Intended Use: Non-Continuous Ventilators providing Intermittent Positive Pressure Breathing (IPPB) assist patients who require periodic respiratory support for lung expansion or secretion mobilization rather than continuous ventilation.

Device Description: Non-Continuous Ventilators are intermittent positive pressure breathing devices that deliver discrete pressure pulses to the airways. These devices are often used in therapeutic settings under clinician direction to improve lung mechanics or support breathing intermittently rather than continuously.

Ventilator, Continuous, Facility Use

Intended Use: Continuous Facility Ventilators are intended to provide ongoing invasive or non-invasive ventilatory support for patients with acute or chronic respiratory failure in healthcare settings such as ICUs, operating rooms, emergency departments, or intra-hospital transport.

Device Description: A Continuous Ventilator is a critical care ventilator system capable of delivering controlled breaths by volume or pressure. It supports multiple ventilation modes (e.g., assist/control, SIMV, pressure support), integrates monitoring and alarms, and is operated by trained healthcare personnel. These devices are designed for extended respiratory support with adjustable settings to meet patient needs.

Ventilatory Effort Recorder

Intended Use: Ventilatory Effort Recorders Are Intended To Monitor And Record Respiratory Effort In Patients As Part Of Respiratory Assessment Or Device Function Evaluation.

Device Description: A Ventilatory Effort Recorder is an electronic monitoring device that measures parameters such as breathing frequency, effort signals, or other respiratory metrics. It interfaces with patient sensors or ventilator output to provide data for clinical evaluation but does not provide direct ventilatory support.

Ventilator, Continuous, Non-Life-Supporting

Intended Use Continuous Non-Life-Supporting Ventilators provide continuous respiratory assistance to patients whose conditions do not require intensive life support, such as certain chronic respiratory insufficiencies or mild to moderate ventilation needs.

Device Description: These ventilators deliver continuous ventilatory support but with simplified functionality compared to full critical care ventilators. They typically feature basic control modes and alarms appropriate for less acute settings under clinician supervision.

Ventilator, Continuous, Minimal Ventilatory Support

Intended Use: Continuous Minimal Ventilatory Support Ventilators are intended to provide gentle respiratory support for patients requiring low-to-moderate levels of assisted ventilation, often in facility settings where full ICU ventilators are not necessary.

Device Description: These devices offer a tailored subset of ventilation modes focused on minimal ventilatory requirements. They include safety monitoring and alarms but may not have the full suite of functions found in high acuity ventilators.

Accessory to Continuous Ventilator

Intended Use Accessories to Continuous Ventilators are intended to support or enhance ventilator function but do not provide independent ventilatory support.

Device Description: This category includes components such as mounting systems, circuit adapters, or specialized interfaces that facilitate ventilator integration, safety, or monitoring. Devices in this category complement ventilator systems but are not ventilators themselves.

Conservator, Oxygen

Intended Use: Oxygen Conservators are intended to enhance oxygen delivery efficiency but are not standalone ventilators.

Device Description: These devices regulate, and conserve supplied oxygen to maximize delivery during specific phases of breathing. They are typically used with patient interfaces or respiratory support equipment in controlled settings.

Device, Positive Pressure Breathing, Intermittent

Intended Use: Intermittent Positive Pressure Breathing Devices provide short bursts of positive pressure to assist inhalation in patients requiring periodic respiratory support.

Device Description: These respirators deliver intermittent positive pressure breaths to augment respiration. They are used under clinical direction and may be similar in function to non-continuous ventilators with IPPB modalities.

Resuscitator, Manual, Non-Self Inflating

Intended Use: Manual Resuscitators provide temporary positive pressure ventilation during emergencies or resuscitation.

Device Description: A Manual Resuscitator features a hand-operated self-inflating bag and patient interface. Squeezing the bag delivers breaths; the device includes valves to control flow and prevent backflow.

Mask, Ventilator, Non-Continuous, Reprocessed

Intended Use: Non-Continuous Ventilator masks are intended to interface between patient and ventilatory device in intermittent ventilation contexts.

Device Description: A patient mask designed for multiple uses that connects to a non-continuous ventilator. Reprocessed variants are cleaned and reused under validated procedures.

Continuous Ventilator, Home Use

Intended Use: Continuous Home-Use Ventilators are intended to provide continuous respiratory support for patients with chronic respiratory insufficiency in the home environment.

Device Description: These ventilators are designed for outpatient or home environments, with portability, simplified interfaces, and safety features suitable for caregiver or patient operation under physician supervision.

Ventilator, Continuous, Minimal Ventilatory Support

Intended Use: These ventilators provide Continuous Minimal Respiratory Support tailored for patients needing low-level ventilation assistance.

Device Description: Devices in this category deliver gentle ventilatory support with limited mode complexity, designed for facility or home use based on clinical need.

Cardiopulmonary Resuscitation Aid Kit

Intended Use: CPR Aid Kits assist in providing Ventilatory Support During Cardiopulmonary resuscitation but are not standalone ventilators.

Device Description: The kit includes tools that facilitate assisted ventilation (e.g., bag-valve interfaces, airway adjuncts) during CPR performed by trained personnel.

Mechanical Ventilator

Intended Use: Mechanical Ventilators are intended to provide continuous invasive or non-invasive ventilation to patients with respiratory failure or insufficiency.

Device Description: These are full-featured ventilator systems that deliver controlled breaths at specified pressures or volumes. Devices include sensors, alarms, and modes supporting a wide range of patient populations and clinical environments.

Ventilatory Electrical Impedance Tomograph

Intended Use: Ventilatory Electrical Impedance Tomographs Are Intended To Monitor Lung Ventilation Patterns Non-Invasively Using Electrical Impedance Measurements.

Device Description: These devices provide images or impedance data related to respiratory patterns, aiding clinicians in assessing lung function but not directly providing ventilation. (Not a ventilator per se.)

Ventilator-Compatible Nebulizer

Intended Use: Ventilator-Compatible Nebulizers are intended to deliver aerosolized medication to ventilated patients through a ventilator circuit.

Device Description: This accessory integrates with a ventilator circuit to enable aerosol therapy without disrupting ventilator functions.

Non-invasive Positive Airway Pressure System, Facility Use

Intended Use: Non-Invasive Positive Airway Pressure Systems provide non-invasive ventilatory support (e.g., CPAP/BiPAP) for patients with respiratory insufficiency.

Device Description: These Continuous Systems Deliver Controlled Positive Airway Pressure through a mask interface to support spontaneous breathing without intubation.

Performance Testing for Ventilators

• Accuracy Of Delivered Tidal Volume And Pressure.
• Reliability And Endurance Testing
• Electromagnetic Compatibility (EMC) And Electrical Safety
• Stability Studies
• Evaluation Of Consistency In Ventilation Parameters Across Repeated Operation Cycles.
• Pressure And Flow Accuracy.
• Leak Compensation.
• Alarm Response Time.
• Software Validation And Cybersecurity
• Biocompatibility Evaluation: The Ventilator’s patient-contacting components are limited to the breathing circuit and patient interface, and all materials are identical to those used in the device with a proven history of safe clinical use. Based on material equivalence, contact type, and duration, no additional biocompatibility testing was required, as typical endpoints (cytotoxicity, sensitization, and irritation/intracutaneous reactivity) are to be addressed for the applicable product codes (ONZ, CBK, NOU, SGR, NMC, BYT).

• Compatibility Testing– always required. Compatibility testing was conducted to verify safe and effective operation of the ventilator when used with compatible breathing circuits, masks, and accessories. Testing included functional performance, alarm response, and electrical and electromagnetic compatibility in accordance with applicable standards.

Clinical Testing:

No Guidance available for 510k submission