Cleared Traditional

K120658 - DURABLUE STERILIZATION WRAP

K120658 is an FDA 510(k) clearance for DURABLUE STERILIZATION WRAP, manufactured by Cardinal Health200, LLC. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K120658 · Cardinal Health200, LLC · General Hospital
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Jun 2012
Decision
100d
Days
Class 2
Risk

K120658 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 13, 2012 after a review of 100 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

FDA 510(k) Submission Details - K120658

510(k) Number K120658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2012
Decision Date June 13, 2012
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

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 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K120658.
ARJORAD STERILE WRAP
K110954 · Arjo Wiggins Medical, Inc. · Aug 2012
FLASHPAK
K113776 · Symmetry Medical · Aug 2012
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · Kimberly-Clark Corp. · Jun 2012
CARDINAL HEALTH DURABLUE STERILIZATION WRAP
K120542 · Cardinal Health-Medical Products and Services · Jun 2012
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
K112591 · Safe Secure Packaging Co., Ltd. · Feb 2012
STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
K112904 · Case Medical, Inc. · Jan 2012