Cleared Traditional

K032568 - BP CUFF BARRIER 1081789

K032568 is the FDA 510(k) clearance for BP CUFF BARRIER 1081789 by Med Textile, LLC. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K032568 · Med Textile, LLC · Cardiovascular device
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Apr 2004
Decision
253d
Days
Class 2
Risk

K032568 is an FDA 510(k) clearance for the BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Med Textile, LLC (Colonial Heights, US). The FDA issued a Cleared decision on April 29, 2004 after a review of 253 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 Med Textile, LLC devices

Submission Details

510(k) Number K032568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date April 29, 2004
Days to Decision 253 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 125d · This submission: 253d
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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K032568.
FLEXIPORT ECOCUFF
K122058 · Welch Allyn, Inc. · Nov 2012
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
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001