Cleared Traditional

K032568 - BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193

K032568 is an FDA 510(k) clearance for BP CUFF BARRIER 1081789, manufactured by Med Textile, LLC. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K032568

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.

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 145
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K032568.
MULTIPLE, MODEL KTJ-50
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ANEROID SPHYGMOMANOMETER, MODEL BK2002
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POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · D. E. Hokanson, Inc. · Aug 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
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CUF-COVER (TM)
K031195 · Ethox Corp. · Oct 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · Card Guard Scientific Survival , Ltd. · Jan 2003