Cleared Traditional

K130722 - AIRCAST VENAFLOW ELITE SYSTEM

K130722 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 94-day FDA review.

K130722 · Djo, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
94d
Days
Class 2
Risk

K130722 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 June 20, 2013 after a review of 94 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 Djo, LLC devices

FDA 510(k) Submission Details - K130722

510(k) Number K130722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date June 20, 2013
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
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 K130722.
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
K131046 · Venous Health Systems, Inc. · Jul 2013
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
K131327 · Bio Compression Systems, Inc. · Jul 2013
CIRONA DVT FOOT GARMENT
K131743 · Devon Medical, Inc. · Jul 2013
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
K131193 · Tactile Systems Technology, Inc. · Jun 2013
DVTCARE CA5
K130174 · Ossur Americas, Inc. · May 2013
DEVON CIRONA 6100 DVT
K130571 · Devon Medical, Inc. · Apr 2013