Cleared Traditional

K932900 - AIRCAST VENAFLOW SYSTEM

K932900 is the FDA 510(k) clearance for AIRCAST VENAFLOW SYSTEM by Aircast, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K932900 · Aircast, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 K932900.
COWBOY X
K944567 · Kinetic Concepts, Inc. · Jun 1995
PRESSSION S III
K942796 · Chattanooga Group, Inc. · Mar 1995
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
K942664 · The Kendal Co. · Jan 1995
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