Cleared Traditional

K131571 - AVD RIGHT RADIAL DRAPE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131571 · Advanced Vascular Dynamics · General Hospital
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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

Submission Details

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
118d slower than avg
Panel avg: 128d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K131571.
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K200238 · Controlrad, Inc. · Apr 2020