Cleared Traditional

K010744 - FLOWTRON UNIVERSAL

K010744 is an FDA 510(k) clearance for FLOWTRON UNIVERSAL, manufactured by Huntleigh Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K010744 · Huntleigh Healthcare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Mar 2002
Decision
378d
Days
Class 2
Risk

K010744 is an FDA 510(k) clearance for the FLOWTRON UNIVERSAL, MODEL AC600. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Huntleigh Healthcare, Inc. (Eatontown, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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. Elevated predicate reliance profile. 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 Huntleigh Healthcare, Inc. devices

FDA 510(k) Submission Details - K010744

510(k) Number K010744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date March 26, 2002
Days to Decision 378 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 125d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 124
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K010744.
REPROCESSED COMPRESSION SLEEVES
K053316 · Alliance Medical Corp. · Feb 2006
REPROCESSED COMPRESSION SLEEVES
K024087 · Alliance Medical Corp. · Mar 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · Alliance Medical Corp. · Mar 2003
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002
COMPRESSIBLE LIMB SLEEVE
K011192 · Alliance Medical Corp. · Nov 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · Microtek Medical, Inc. · Oct 2001