Cleared Traditional

K190902 - RH non-Automated Blood Pressure Meter R...

K190902 is the FDA 510(k) clearance for RH non-Automated Blood Pressure Meter R... by Wenzhou Renhua Instruments Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K190902 · Wenzhou Renhua Instruments Co., Ltd. · Cardiovascular device
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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.

View all Wenzhou Renhua Instruments Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · 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

All 73
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K190902.
Disposable NIBP Cuff
K193629 · Shenzhen Changke Connect Electronics Co., Ltd. · Mar 2020
Reusable NIBP Cuff
K191253 · Shenzhen Changke Connect Electronics Co., Ltd. · Sep 2019
Aneroid Type Blood Pressure Kit
K191209 · Dongguan Mars Medical Products Co., Ltd. · Jun 2019
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 2018
Reusable NIBP Cuff
K173197 · Orantech, Inc. · Aug 2018
Med-link Reusable Blood Pressure Cuff
K173869 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 2018