Cleared Traditional

K992454 - VENAFLOW SYSTEM, MODEL 30A

K992454 is an FDA 510(k) clearance for 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 174-day FDA review.

K992454 · Aircast, Inc. · Cardiovascular device
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Jan 2000
Decision
174d
Days
Class 2
Risk

K992454 is an FDA 510(k) clearance for the VENAFLOW SYSTEM, MODEL 30A. 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 January 13, 2000 after a review of 174 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 - K992454

510(k) Number K992454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1999
Decision Date January 13, 2000
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 K992454.
VENODYNE DVT ADVANTAGE MODEL 610
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K991038 · Britt Corp., Inc. · Jun 2000
PROAIR 3000 COMPRESSION SYSTEM
K993758 · Medical Compression Systems (Dbn) , Ltd. · May 2000
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · The Kendall Company, L.P. · Sep 1999
WALKCARE P200 SYSTEM
K973592 · A.Stein - Regulatory Affairs Consulting · May 1999
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · Delphi Consulting Group · Apr 1999