Blood Pressure Monitor

FDA 510k for Blood Pressure Monitor

(Automatic Blood Pressure Monitor)


FDA 510k for Blood Pressure Monitor – An overview

The FDA 510(k) is mandatory for Blood Pressure Monitor (Automatic /non-automatic) to be marketed in the United States. Here’s an overview.

  • The device must be substantially equivalent to a predicate device
  • The device used for comparison must be one that was legally marketed before May 28, 1976
  • Requires comprehensive documentation and substantial evidence of equivalence
  • Devices undergo rigorous review, and any deficiencies must be addressed promptly.


The Device Description

An automatic blood pressure monitor is a medical device used to measure blood pressure without the need for manual inflation or auscultation (listening for sounds). These monitors typically consist of a cuff that wraps around the upper arm, a display unit, and electronic components for measurement and display.

An automatic blood pressure monitor is a device that utilizes an air pump to inflate a cuff wrapped on the patient’s upper arm. The cuff is inflated to a pressure that prevents blood flown into the local main artery. The device sensor can then measure the maximum blood pressure values. The diastolic pressure is when the flow goes from an intermittent to a continuous flow. Both readings are reflected on a digital screen.

Automatic blood pressure monitors are designed for convenience and accuracy, allowing individuals to monitor their blood pressure at home or in clinical settings without requiring a healthcare professional to take the readings manually. They are handy for people with hypertension or those needing frequent blood pressure monitoring.

Documents for 510k submission

  1. Medical Device User Fee Cover Sheet
  2. 510(k) Cover Letter
  3. Indications for Use
  4. 510(k) Summary
  5. Medical Device Description
  6. Substantial Equivalence Discussion
  7. Proposed Labeling
  8. Biocompatibility
  9. Software
  10. Electromagnetic Compatibility and Electrical Safety
  11. Performance Testing-Bench

FDA Classification for Automatic Blood Pressure Monitor

Regulation Number Automatic Blood pressure monitor Code Automatic Blood pressure monitor Class Automatic Blood pressure monitor Type
870.1130 DXN Class 2 System, Measurement, Blood Pressure, Non-Invasive


FDA 510k test requirements for Blood Pressure Monitor

EMC Test:

IEC 60601-1-2 Edition 4:2014, Medical Electrical Equipment – Part 1- 2: General requirements for safety – collateral standard: Electromagnetic compatibility – Requirements and Tests

Biocompatibility Test:

ISO 10993-1:2018, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.

ISO 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10:2010, Third Edition Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization

Safety Test:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-1-11:2015, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance– Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment.

Reliability Test:

IEC 80601-2-30 Edition1.1 2013-07 Medical electrical equipment-Part 2-30: Requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

Storage test, Operating test, Vibration test, Drop test, Life test.

Risk Assessment:

ISO 14971:2007 Second Edition, Medical devices – Application of risk management to medical devices

Software Verification and Validation:

IEC 62304 Ed.1.0 (2006), Medical device software – Software life cycle processes

IEC 60601-1-4 Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems, edition 1.1 Safety test

Usability Validation:

IEC 62366:2014 Medical devices – Application of usability engineering to medical devices

IEC 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

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Tags # 510K # 510k blood pressure monitor Page developed by Any Lieu Dated 27.05 2024