# K182166: Wrist Blood Pressure Monitor Model BP4350

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 8, 2018 after 90 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 K042505 (2005). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142917: BP652N (Hem-6300-Z), Omron Healthcare, Inc. (2014) Summary page 5.

## Most influential descendants
- K212115: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (2022), 5 descendants of its own
- K230566: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (2023), 2 descendants of its own
- K250548: Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (2025), 1 descendant of its own
- K211288: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (2021), 1 descendant of its own
- K261394: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) (2026), 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 wrist circumference ranging from 5.3 inches to 8.5 inches (13.5cm to 21.5cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K182166
Methodology: https://510kreport.com/methodology