Cleared Special

K061762 - TIBURON DRAPE

K061762 is an FDA 510(k) clearance for TIBURON DRAPE, manufactured by Cardinal Health, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Special 510(k) pathway after a 40-day FDA review.

K061762 · Cardinal Health, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
40d
Days
Class 2
Risk

K061762 is an FDA 510(k) clearance for the TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K061762

510(k) Number K061762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2006
Decision Date August 01, 2006
Days to Decision 40 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

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 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K061762.
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009
BUSSE SURGICAL DRAPE
K082297 · Busse Hospital Disposables, Inc. · Dec 2008
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007
EQUIPMENT SLUSH DRAPE
K053495 · Advance Medical Designs, Inc. · Mar 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005