Cleared Traditional

K112918 - DURABLUE STERILIZATION (AMSCO V-PRO) WRAP

K112918 is the FDA 510(k) clearance for DURABLUE STERILIZATION (AMSCO V-PRO) WRAP by Cardinal Health200, LLC. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K112918 · Cardinal Health200, LLC · General Hospital
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Jan 2012
Decision
109d
Days
Class 2
Risk

K112918 is an FDA 510(k) clearance for the DURABLUE STERILIZATION (AMSCO V-PRO) 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 January 20, 2012 after a review of 109 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K112918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date January 20, 2012
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K112918.
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
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
K103210 · Advanced Sterilization Products · Jun 2011
AESCULAP STERILCONTAINER S
K093493 · Aesculap, Inc. · Jul 2010