Cleared Traditional

K012675 - REPROCESSED USED DISPOSABLE SEQUENTIAL ...

K012675 is an FDA 510(k) clearance for REPROCESSED USED DISPOSABLE SEQUENTIAL ..., manufactured by Adven Medical. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K012675 · Adven Medical · Cardiovascular device
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Feb 2002
Decision
182d
Days
Class 2
Risk

K012675 is an FDA 510(k) clearance for the REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 182 days - an extended review 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: 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 Adven Medical devices

FDA 510(k) Submission Details - K012675

510(k) Number K012675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date February 12, 2002
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 116
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K012675.
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
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · Sterilmed, Inc. · Oct 2001