Cleared Traditional

K932900 - AIRCAST VENAFLOW SYSTEM

K932900 is an FDA 510(k) clearance for AIRCAST VENAFLOW 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 133-day FDA review.

K932900 · Aircast, Inc. · Cardiovascular device
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Oct 1993
Decision
133d
Days
Class 2
Risk

K932900 is an FDA 510(k) clearance for the AIRCAST VENAFLOW SYSTEM. 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 October 25, 1993 after a review of 133 days - within the typical 510(k) review window.

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 - K932900

510(k) Number K932900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date October 25, 1993
Days to Decision 133 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
8d slower than avg
Panel avg: 125d · This submission: 133d
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 K932900.
PRESSSION S III
K942796 · Chattanooga Group, Inc. · Mar 1995
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
K942664 · The Kendal Co. · Jan 1995
INTERMITTENT COMPRESSION SYSTEM MODEL 5000
K930526 · Advanced Instruments, Inc. · Nov 1993
SCD(R) CONTROLLER
K933259 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1993
KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE
K932835 · Kendall Healthcare Products Co. Div.Of Tyco Health · Aug 1993
COWBOY III
K932215 · Kinetic Concepts, Inc. · Jul 1993