Cleared Traditional

Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (K251581) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251581 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Cardiovascular device
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Feb 2026
Decision
266d
Days
Class 2
Risk

K251581 is an FDA 510(k) clearance for the Wearable Ambulatory Blood Pressure Monitor (WBP-02A). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Shenzhen Hingmed Medical Instrument Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 13, 2026 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Hingmed Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K251581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2025
Decision Date February 13, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 281
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K251581.
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
K260273 · Shenzhen Urion Technology Co., Ltd. · Mar 2026
YUWELL® Electronic Blood Pressure Monitor (YE630CR)
K252779 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Mar 2026
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
K253228 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
K252685 · Joytech Healthcare Co. , Ltd. · Feb 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
K253133 · Shenzhen Imdk Medical Technology Co., Ltd. · Feb 2026
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
K251307 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Jan 2026