# K131742: HEM-6131

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Jul 24, 2013 after 41 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: 1 generation back to K042505 (2005). 1 ancestor in all.
15 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N, Omron Healthcare, Inc. (2005) Summary page 1.

## Most influential descendants
- K182127: Wrist Blood Pressure Monitor Model BP6100 (2018), 11 descendants of its own
- K212115: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor (2022), 5 descendants of its own
- K231310: Electronic Blood Pressure Monitor (2023), 3 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

## 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 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K131742
Methodology: https://510kreport.com/methodology