Cleared Traditional

K023800 - VENAFLOW REUSABLE CALF AIRCELL

K023800 is the FDA 510(k) clearance for VENAFLOW REUSABLE CALF AIRCELL by Aircast, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K023800 · Aircast, Inc. · Cardiovascular device
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Feb 2003
Decision
88d
Days
Class 2
Risk

K023800 is an FDA 510(k) clearance for the VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, M.... Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on February 10, 2003 after a review of 88 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 Aircast, Inc. devices

Submission Details

510(k) Number K023800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date February 10, 2003
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K023800.
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