Cleared Traditional

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (K251307) - FDA 510(k) Clearance

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

K251307 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Cardiovascular device
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Jan 2026
Decision
259d
Days
Class 2
Risk

K251307 is an FDA 510(k) clearance for the Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i). 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 January 12, 2026 after a review of 259 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 K251307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2025
Decision Date January 12, 2026
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K251307.
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · Shenzhen Hingmed Medical Instrument 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
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
K253142 · Ningbo Ranor Medical Technology Co., Ltd. · Jan 2026
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
K251143 · Ningbo Ranor Medical Science & Technology Co., Ltd. · Dec 2025
Blood Pressure Monitor (B73, BE23T)
K251331 · Shenzhen Jamr Technology Co., Ltd. · Oct 2025