Cleared Traditional

K933977 - AIRCAST EDEMAFLOW SYSTEM

K933977 is the FDA 510(k) clearance for AIRCAST EDEMAFLOW SYSTEM by Aircast, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K933977 · Aircast, Inc. · Cardiovascular device
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Dec 1993
Decision
116d
Days
Class 2
Risk

K933977 is an FDA 510(k) clearance for the AIRCAST EDEMAFLOW 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 December 7, 1993 after a review of 116 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 K933977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1993
Decision Date December 07, 1993
Days to Decision 116 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
9d faster than avg
Panel avg: 125d · This submission: 116d
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 K933977.
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