(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