Cleared Traditional

K964238 - AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS

K964238 is an FDA 510(k) clearance for AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS, 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 320-day FDA review.

K964238 · Aircast, Inc. · Cardiovascular device
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Sep 1997
Decision
320d
Days
Class 2
Risk

K964238 is an FDA 510(k) clearance for the AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS. 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 September 8, 1997 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K964238

510(k) Number K964238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date September 08, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
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 270
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K964238.
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TRINITY DVT SYSTEM
K963957 · Delphi Consulting Group · Nov 1997
TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
K970014 · Delphi Consulting Group · Aug 1997
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K964425 · Powell,Goldstein,Frazer & Murphy · Jul 1997
HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
K964188 · Healthcare Service and Supply · May 1997