Cleared Traditional

K024019 - ARTERIALFLOW SYSTEM, MODEL 32A

K024019 is an FDA 510(k) clearance for ARTERIALFLOW SYSTEM, manufactured by Aircast, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K024019 · Aircast, Inc. · Cardiovascular device
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Jun 2003
Decision
180d
Days
Class 2
Risk

K024019 is an FDA 510(k) clearance for the ARTERIALFLOW SYSTEM, MODEL 32A. 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 June 3, 2003 after a review of 180 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 Aircast, Inc. devices

FDA 510(k) Submission Details - K024019

510(k) Number K024019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2002
Decision Date June 03, 2003
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 271
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K024019.
MODEL SC-3008 SEQUENTIAL CIRCULATOR
K043423 · Bio Compression Systems, Inc. · Feb 2005
FLOWMEDIC, MODEL 220
K042217 · Flowmedic (Israel), Ltd. · Jan 2005
C-BOOT
K041659 · C-Boot , Ltd. · Oct 2004
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