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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 Peers - FRG Wrap, Sterilization

All 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K120542.
DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION
K122507 · Cardinal Health200, LLC · Sep 2012
KIMGUARD ONE-STEP STERILIZATION WRAP
K112805 · Kimberly-Clark Corp. · Jun 2012
DURABLUE STERILIZATION WRAP
K120658 · Cardinal Health200, LLC · Jun 2012
DURABLUE STERILIZATION (AMSCO V-PRO) WRAP
K112918 · Cardinal Health200, LLC · Jan 2012
KIMGUARD SMART-FOLD* STERILIZATION WRAP
K112300 · Kimberly-Clark Corp. · Jan 2012
DURA BLUE STERILIZATION WRAP
K112211 · Cardinal Health200, LLC · Oct 2011