21 CFR 870.1135 — Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1135

Identification

The Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ) and BP5460 (HEM-7372T1-AZAZ)) is an oscillometric-based, over-the-counter, upper arm blood pressure monitor intended for use in adults (22 years or older) to measure blood pressure and pulse rate. It includes an AFib detection feature that analyzes pulse pressure wave data captured during blood pressure measurement to identify episodes of atrial fibrillation and provide a notification on the display screen. It is intended for home screening for the possibility of AFib and is not intended to replace traditional diagnosis or treatment or to be used in the management of patients with known AFib.

Classification Rationale

Class II (special controls). The device is classified as Class II under 21 CFR 870.1135, subject to special controls to mitigate risks such as false positives, false negatives, and misinterpretation of device output.

Product Codes