# K162092: Evolv Model BP7000 Upper Arm Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 22, 2016 after 117 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). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133383: HEM-7320, Omron Healthcare, Inc. (2014) Summary page 5.

## Most influential descendants
- K253059: Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (2026), 0 descendants of its own
- K252779: YUWELL® Electronic Blood Pressure Monitor (YE630CR) (2026), 0 descendants of its own
- K241431: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (2025), 0 descendants of its own

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (22cm to 42cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K162092
Methodology: https://510kreport.com/methodology