# K081590: YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U, BP-600B, BP-600RB, BP-600UB, BP-600J

- Pathway: 510(k) (Traditional)
- Applicant: Ya Horng Electronic Co., Ltd.
- Decided: Jun 19, 2008 after 13 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: 5 generations back to K903134 (1991). 6 ancestors in all.
46 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060686: Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC, Microlife Intellectual Property GmbH (2006) Summary page 1.

## Most influential descendants
- K083093: Cheetah Reliant (2008), 45 descendants of its own
- K101487: Cheetah Nicom System (2010), 35 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), 27 descendants of its own
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (2021), 18 descendants of its own

## Indications for use
The Arm Type Digital Blood Pressure Monitor is a table top AC/DC powered operated arm type blood pressure monitor which is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. The measurement is by the oscillometric method wherein a cuff is placed on the upper arm and the pressure in the cuff is increased until the blood flow in the artery is interrupted and then the pressure in the cuff is slowly reduced. The measurement result is shown on a LCD panel in the monitor. The measuring ranges are (1) blood pressure: 20 to 280 mmHg (2) pulse: 40 to 200 pulses/minutes.

Source page: https://510kreport.com/device/K081590
Methodology: https://510kreport.com/methodology