Cleared Traditional

K012403 - VANGUARD REPROCESSED COMPRESSION GARMENT

K012403 is an FDA 510(k) clearance for VANGUARD REPROCESSED COMPRESSION GARMENT, manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K012403 · Vanguard Medical Concepts, Inc. · Cardiovascular device
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Oct 2001
Decision
79d
Days
Class 2
Risk

K012403 is an FDA 510(k) clearance for the VANGUARD REPROCESSED COMPRESSION GARMENT. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on October 17, 2001 after a review of 79 days - a notably fast clearance cycle.

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: 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 Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K012403

510(k) Number K012403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2001
Decision Date October 17, 2001
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K012403.
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc. · Feb 2002
COMPRESSIBLE LIMB SLEEVE
K011192 · Alliance Medical Corp. · Nov 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · Sterilmed, Inc. · Oct 2001
SOF. PRESS EPC 51 SYSTEM
K963067 · Gaymar Industries, Inc. · Jan 1997
REDOX
K953850 · Kinetic Concepts, Inc. · Mar 1996
COWBOY X
K944567 · Kinetic Concepts, Inc. · Jun 1995