Cleared Traditional

K060871 - AS101, BLOOD PRESSURE CUFF

K060871 is an FDA 510(k) clearance for AS101, manufactured by Wenzhou Longwan Medical Instrument Company. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K060871 · Wenzhou Longwan Medical Instrument Company · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
71d
Days
Class 2
Risk

K060871 is an FDA 510(k) clearance for the AS101, BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Wenzhou Longwan Medical Instrument Company (Flintville, US). The FDA issued a Cleared decision on June 9, 2006 after a review of 71 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 Longwan Medical Instrument Company devices

FDA 510(k) Submission Details - K060871

510(k) Number K060871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2006
Decision Date June 09, 2006
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 134
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K060871.
ERKA. PERFECT-ANEROID
K103637 · Erka Kallmeyer Medizintechnik GmbH · Jun 2011
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
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
K053006 · Rossmax Internationl , Ltd. · Feb 2006
ALL PURPOSE CUFF, MODEL 222APC
K051904 · Suntech Medical, Inc. · Sep 2005
TRICOT BLOOD PRESSURE CUFF
K051539 · Ya Horng Electronic Co., Ltd. · Aug 2005