# K171833: Digital Blood Pressure Monitor-Wrist Style

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Combei Technology Co., Ltd.
- Decided: Jan 10, 2018 after 205 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: 10 generations back to K001670 (2000). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor, Fudakang Industrial Co., Ltd. (2015) Summary page 5.

## Most influential descendants
- K220651: Wrist Type Blood Pressure Monitor (2022), 2 descendants of its own
- K230409: Wrist Type Blood Pressure Monitor (W05,W1101L) (2023), 1 descendant of its own
- K253570: Blood Pressure Monitor (W06LT) (2026), 0 descendants of its own
- K190982: Automatic Digital Blood Pressure Monitor (2020), 0 descendants of its own

## Indications for use
The subject device is intended to measure the diastolic, systolic blood pressures and pulse rate of an adult individual in hospitals, hospital-type facilities and home environments by using a non-invasive oscillometric technique in which an inflatable cuff(size: 12.5-21.5cm(4.9-8.5in) is wrapped around the single wrist. The Subject device is not intended to be diagnostic device.

Source page: https://510kreport.com/device/K171833
Methodology: https://510kreport.com/methodology