# K142917: BP652N (Hem-6300-Z)

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Dec 1, 2014 after 55 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: 2 generations back to K042505 (2005). 3 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123498: BP652N (Hem-6300-Z), Omron Healthcare, Inc. (2013) Summary page 4.
- K003732: Braun Precision Sensor, Model BP 2000 Series, Braun GmbH (2001) Summary page 4.

## Most influential descendants
- K182166: Wrist Blood Pressure Monitor Model BP4350 (2018), 10 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
- K160557: Full Automatic (NIBP) Blood Pressure Monitor (2016), 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
- K163045: Omron HEM-6400T-Z Wrist Blood Pressure Monitor (2017), 2 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 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/K142917
Methodology: https://510kreport.com/methodology