Cleared Traditional

K131571 - AVD RIGHT RADIAL DRAPE

K131571 is an FDA 510(k) clearance for AVD RIGHT RADIAL DRAPE, manufactured by Advanced Vascular Dynamics. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K131571 · Advanced Vascular Dynamics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
246d
Days
Class 2
Risk

K131571 is an FDA 510(k) clearance for the AVD RIGHT RADIAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Advanced Vascular Dynamics (Milwaukie, US). The FDA issued a Cleared decision on January 31, 2014 after a review of 246 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Vascular Dynamics devices

FDA 510(k) Submission Details - K131571

510(k) Number K131571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2013
Decision Date January 31, 2014
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.

Regulatory Peers - KKX Drape, Surgical

All 207
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K131571.
3M STERI-DRAPE FABRIC SURGICAL DRAPES
K140330 · 3M Healthcare · Aug 2014
3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
K140250 · 3M Healthcare · Jul 2014
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
TIBURON SURGICAL DRAPE
K130404 · Cardinal Health200, LLC · Jul 2013
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010
BUSSE SURGICAL DRAPES IV
K093909 · Busse Hospital Disposables, Inc. · May 2010