FDA 510(k) · Shenzhen Hingmed Medical Instrument
K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (Shenzhen Hingmed Medical Instrument Co., Ltd.)
Shenzhen Hingmed Medical Instrument Co., Ltd. received FDA 510(k) K251581 for Wearable Ambulatory Blood Pressure Monitor (WBP-02A), with a decision date of Feb 13, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K251581 |
|---|---|
| Pathway | 510(k) |
| Applicant | Shenzhen Hingmed Medical Instrument Co., Ltd. |
| Device name | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | May 23, 2025 |
| Decision date | Feb 13, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.