Cleared Traditional

K122499 - AIRCAST VENAFLOW ELITE SYSTEM

K122499 is an FDA 510(k) clearance for AIRCAST VENAFLOW ELITE SYSTEM, manufactured by Djo, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K122499 · Djo, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
63d
Days
Class 2
Risk

K122499 is an FDA 510(k) clearance for the AIRCAST VENAFLOW ELITE SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Djo, LLC (Vista, US). The FDA issued a Cleared decision on October 18, 2012 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Djo, LLC devices

FDA 510(k) Submission Details - K122499

510(k) Number K122499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2012
Decision Date October 18, 2012
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
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 220
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K122499.
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