Cleared Traditional

K130404 - TIBURON SURGICAL DRAPE

K130404 is an FDA 510(k) clearance for TIBURON SURGICAL DRAPE, manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K130404 · Cardinal Health200, LLC · General Hospital
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Jul 2013
Decision
136d
Days
Class 2
Risk

K130404 is an FDA 510(k) clearance for the TIBURON SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 5, 2013 after a review of 136 days - within the typical 510(k) review window.

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 Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K130404

510(k) Number K130404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date July 05, 2013
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
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 263
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K130404.
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