Cleared Traditional

BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 (K032568) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032568 · Med Textile, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 197
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K032568.
YP-710T Series NIBP Cuff
K260747 · Nihon Kohden Corporation · May 2026
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
K253089 · Shenzhen Best Electronics Co., Ltd. · Feb 2026
Disposable Neonatal NIBP Cuff (U1681S-C51N)
K253964 · Unimed Medical Supplies, Inc. · Jan 2026
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · Baxter Healthcare Corporation · Dec 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · Unimed Medical Supplies, Inc. · Jul 2025