Cleared Traditional

K123289 - DURABLUE STERILIZATION WRAP

K123289 is an FDA 510(k) clearance for DURABLUE STERILIZATION WRAP, manufactured by Cardinal Health-Medical Products and Services. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K123289 · Cardinal Health-Medical Products and Services · General Hospital
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Feb 2013
Decision
129d
Days
Class 2
Risk

K123289 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 Health-Medical Products and Services (Waukegan, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 129 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 Health-Medical Products and Services devices

FDA 510(k) Submission Details - K123289

510(k) Number K123289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2012
Decision Date February 28, 2013
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K123289.
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · STERIS Corporation · Jul 2014
DURABLUE STERILIZATION WRAP
K130927 · Cardinal Health200, LLC · Jun 2013
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013
DURABLUE STERILIZATION WRAP
K123857 · Cardinal Health200, LLC · Jan 2013
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
K122507 · Cardinal Health200, LLC · Sep 2012