Cleared Traditional

K143053 - KIMGUARD ONE-STEP Sterilization Wrap

K143053 is an FDA 510(k) clearance for KIMGUARD ONE-STEP Sterilization Wrap, manufactured by Kimberly-Clark Health Care. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K143053 · Kimberly-Clark Health Care · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
162d
Days
Class 2
Risk

K143053 is an FDA 510(k) clearance for the KIMGUARD ONE-STEP Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Kimberly-Clark Health Care (Roswell, US). The FDA issued a Cleared decision on April 3, 2015 after a review of 162 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 Kimberly-Clark Health Care devices

FDA 510(k) Submission Details - K143053

510(k) Number K143053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2014
Decision Date April 03, 2015
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
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 149
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K143053.
Cardinal Health Sterilization Wrap
K151788 · Cardinal Health200, LLC · Oct 2015
Wire Sterilization Package with Indicators
K143117 · American Orthodontics · Oct 2015
Gemini Bonded Sterilization Wrap
K143147 · Medline Industries, Inc. · May 2015
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · Advanced Sterilization Products · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · STERIS Corporation · Jul 2014