# K123498: BP652N (Hem-6300-Z)

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Mar 21, 2013 after 128 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.
21 later devices descend from it; 2 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)
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N, Omron Healthcare, Inc. (2005) Summary page 1.

## Most influential descendants
- K142917: BP652N (Hem-6300-Z) (2014), 19 descendants of its own
- 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

## 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 wit readings.

Source page: https://510kreport.com/device/K123498
Methodology: https://510kreport.com/methodology