# K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hingmed Medical Instrument Co., Ltd.
- Decided: Feb 13, 2026 after 266 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: 9 generations back to K903134 (1991). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151520: Oscar 2, Suntech Medical, Inc. (2016) Summary page 6.

## Indications for use
The Wearable Ambulatory Blood Pressure Monitor, model WBP-02A is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to measure systolic and diastolic pressure in individuals aged 12 years and older. The collected data can be transmitted to a PC via USB for healthcare professionals to review and analyze. This device is not intended for diabetic patients, pregnant women, or patients with arrhythmia. It is intended for prescription use only.

Source page: https://510kreport.com/device/K251581
Methodology: https://510kreport.com/methodology