Cleared Traditional

K112211 - DURA BLUE STERILIZATION WRAP

K112211 is an FDA 510(k) clearance for DURA BLUE 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 79-day FDA review.

K112211 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
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Oct 2011
Decision
79d
Days
Class 2
Risk

K112211 is an FDA 510(k) clearance for the DURA BLUE 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 October 20, 2011 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardinal Health200, LLC devices

FDA 510(k) Submission Details - K112211

510(k) Number K112211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2011
Decision Date October 20, 2011
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K112211.
STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS
K112904 · Case Medical, Inc. · Jan 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
K112283 · Cardinal Health200, LLC · Oct 2011
STERI-DENT, STERI-SURE
K110867 · Cpac, Inc. · Jul 2011
TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
K103210 · Advanced Sterilization Products · Jun 2011

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.