Cleared Special

K130927 - DURABLUE STERILIZATION WRAP

K130927 is the FDA 510(k) clearance for DURABLUE STERILIZATION WRAP by Cardinal Health200, LLC. It is a Class 2 General Hospital device (product code FRG) cleared through the Special 510(k) pathway after a 76-day FDA review.

K130927 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
76d
Days
Class 2
Risk

K130927 is an FDA 510(k) clearance for the DURABLUE STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 18, 2013 after a review of 76 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Health200, LLC devices

Submission Details

510(k) Number K130927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2013
Decision Date June 18, 2013
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 119
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K130927.
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · Advanced Sterilization Products · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · STERIS Corporation · Jul 2014
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · Kimberly-Clark Corp. · Jun 2012
KIMGUARD SMART-FOLD* STERILIZATION WRAP
K112300 · Kimberly-Clark Corp. · Jan 2012