510(k) K251581
K251581 is an FDA 510(k) premarket notification submitted by Shenzhen Hingmed Medical Instrument Co., Ltd. for the device "Wearable Ambulatory Blood Pressure Monitor (WBP-02A)". The FDA issued a decision of Substantially Equivalent on Feb 13, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen Hingmed Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2026
- Date Received
- May 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type