Cleared Traditional

K013297 - AIRCAST, MODEL #3011

K013297 is an FDA 510(k) clearance for AIRCAST, manufactured by Millenium Reprocessing Services, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K013297 · Millenium Reprocessing Services, Inc. · Cardiovascular device
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Jun 2002
Decision
254d
Days
Class 2
Risk

K013297 is an FDA 510(k) clearance for the AIRCAST, MODEL #3011. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Millenium Reprocessing Services, Inc. (Clarence, US). The FDA issued a Cleared decision on June 14, 2002 after a review of 254 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 Millenium Reprocessing Services, Inc. devices

FDA 510(k) Submission Details - K013297

510(k) Number K013297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2001
Decision Date June 14, 2002
Days to Decision 254 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
129d slower than avg
Panel avg: 125d · This submission: 254d
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 235
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K013297.
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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