Cleared Traditional

K171889 - Reusable Blood Pressure Cuff

K171889 is an FDA 510(k) clearance for Reusable Blood Pressure Cuff, manufactured by Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K171889 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Cardiovascular device
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Dec 2017
Decision
176d
Days
Class 2
Risk

K171889 is an FDA 510(k) clearance for the Reusable Blood Pressure Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Suzhou Minhua Medical Apparatus Supplies Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on December 19, 2017 after a review of 176 days - an extended review 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: 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 Suzhou Minhua Medical Apparatus Supplies Co., Ltd. devices

FDA 510(k) Submission Details - K171889

510(k) Number K171889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date December 19, 2017
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

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 88
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K171889.
Med-link Reusable Blood Pressure Cuff
K173869 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Aug 2018
ANEROID SPHYGMOMANOMETER
K173246 · Wenzhou Bokang Instruments Co., Ltd. · May 2018
Accutension Smartphone Auscultatory Blood
K180335 · Shanghai Hulu Devices Co., Ltd. · Mar 2018
Medline Singe Patient Use Blood Pressure Cuff
K161035 · Medline Industries, Inc. · Jun 2016
Cogent Hemodynamic Monitoring System
K152006 · Icu Medical, Inc. · May 2016
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015