Cleared Traditional

K120542 - CARDINAL HEALTH DURABLUE STERILIZATION WRAP

K120542 is an FDA 510(k) clearance for CARDINAL HEALTH 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 99-day FDA review.

K120542 · Cardinal Health-Medical Products and Services · General Hospital
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Jun 2012
Decision
99d
Days
Class 2
Risk

K120542 is an FDA 510(k) clearance for the CARDINAL HEALTH 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 June 1, 2012 after a review of 99 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 - K120542

510(k) Number K120542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date June 01, 2012
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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.
NED DEVINE

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 K120542.
FLASHPAK
K113776 · Symmetry Medical · Aug 2012
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · Kimberly-Clark Corp. · Jun 2012
DURABLUE STERILIZATION WRAP
K120658 · Cardinal Health200, LLC · 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
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · Cardinal Health200, LLC · Jan 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.