Cleared Traditional

K081951 - ANEROID SPHYGMOMANOMETER, MODEL KT-A01

K081951 is an FDA 510(k) clearance for ANEROID SPHYGMOMANOMETER, manufactured by Wenzhou Kindcare Import & Export Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K081951 · Wenzhou Kindcare Import & Export Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
37d
Days
Class 2
Risk

K081951 is an FDA 510(k) clearance for the ANEROID SPHYGMOMANOMETER, MODEL KT-A01. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wenzhou Kindcare Import & Export Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on August 15, 2008 after a review of 37 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 Kindcare Import & Export Co., Ltd. devices

FDA 510(k) Submission Details - K081951

510(k) Number K081951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2008
Decision Date August 15, 2008
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXQ Blood Pressure Cuff

All 143
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K081951.
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
K080854 · Suntech Medical, Inc. · Oct 2008
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A
K082542 · Cardicare Company, Ltd. · Sep 2008
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX
K080189 · Trimline Medical Products Corp. · Aug 2008
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
K080366 · Zefon Intl. · Jun 2008
MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
K071244 · Medline Industries, Inc. · Mar 2008
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · Welch Allyn, Inc. · Dec 2007