# K261929: Upper Arm Blood pressure monitor (BP7155D)

- Pathway: 510(k) (Special)
- Applicant: OMRON Healthcare, Inc.
- Decided: Sep 10, 2026 after 93 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: 3 generations back to K052153 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133379: HEM-7311, Omron Healthcare, Inc. (2014) Summary page 5.

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K261929
Methodology: https://510kreport.com/methodology