# K202228: Omron Model BP7900 Blood Pressure Monitor + EKG

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Apr 1, 2021 after 237 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182579: Omron Model BP7900 Blood Pressure Monitor + EKG, Omron Healthcare, Inc. (2019) Summary page 4.
- K191406: KardiaMobile, KardiaStation, AliveCor, Inc. (2020) Summary page 4.

## Indications for use
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously. The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K202228
Methodology: https://510kreport.com/methodology