Cleared Traditional

K190902 - RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (FDA 510(k) Clearance)

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

K190902 · Wenzhou Renhua Instruments Co., Ltd. · Cardiovascular device
May 2019
Decision
44d
Days
Class 2
Risk

K190902 is an FDA 510(k) clearance for the RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter w.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wenzhou Renhua Instruments Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on May 22, 2019 after a review of 44 days — a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 — 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment — the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K190902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2019
Decision Date May 22, 2019
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 140d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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 - DXQ Blood Pressure Cuff

Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K190902.
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
K253089 · Shenzhen Best Electronics Co., Ltd. · Feb 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · Unimed Medical Supplies, Inc. · Jan 2026
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · Baxter Healthcare Corporation · Dec 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · Unimed Medical Supplies, Inc. · Jul 2025
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023