Cleared Traditional

K151445 - Cardinal Health Sterilization Wrap

K151445 is an FDA 510(k) clearance for Cardinal Health 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 206-day FDA review.

K151445 · Cardinal Health200, LLC · General Hospital
Download Printable Device Report (PDF)
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Dec 2015
Decision
206d
Days
Class 2
Risk

K151445 is an FDA 510(k) clearance for the Cardinal Health 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 December 21, 2015 after a review of 206 days - an extended review 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: 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 Health200, LLC devices

FDA 510(k) Submission Details - K151445

510(k) Number K151445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2015
Decision Date December 21, 2015
Days to Decision 206 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 129d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K151445.
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
K152669 · Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std · Jan 2016
Turbett Surgical Container
K153025 · Turbett Surgical, LLC · Jan 2016
Sterisheet Sterilization Wrap
K152291 · Andersen Sterilizers, Inc. · Dec 2015
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015
Tyvek Sterilization Pouches with Chevron Seal
K152058 · Andersen Sterilizers, Inc. · Nov 2015