Cleared Traditional

K131146 - ARTASSIST AND VENASSIST

K131146 is an FDA 510(k) clearance for ARTASSIST AND VENASSIST, manufactured by Aci Medical, LLC. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K131146 · Aci Medical, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
293d
Days
Class 2
Risk

K131146 is an FDA 510(k) clearance for the ARTASSIST AND VENASSIST. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Aci Medical, LLC (San Marcos, US). The FDA issued a Cleared decision on February 10, 2014 after a review of 293 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.

FDA 510(k) Submission Details - K131146

510(k) Number K131146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2013
Decision Date February 10, 2014
Days to Decision 293 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
168d slower than avg
Panel avg: 125d · This submission: 293d
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 342
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K131146.
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
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K133119 · Arjohuntleigh Polska SP Z.O.O. · Feb 2014
VENA PRO
K133274 · Innovamed Health, LLC · Feb 2014
WRIGHT GRADIENT 52 - TORSO
K131387 · Wright Therapy Products, Inc. · Nov 2013
PETITE BASIC SYSTEM 701 ELT
K131420 · Mego Afek AC , Ltd. · Nov 2013
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K132360 · Covidien · Aug 2013
K131146 · ARTASSIST AND VENASSIST
Download PDF FDA Summary Aci Medical, LLC