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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRG Wrap, Sterilization

All 245
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K123289.
DURABLUE STERILIZATION WRAP
K132060 · Cardinal Health-Medical Products and Services · Dec 2013
KIMGUARD ONE STEP STERILIZATION WRAP
K113806 · Kimberly-Clark Health Care · Aug 2013
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

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.