Cleared Traditional

K140963 - KIMGUARD SMART-FOLD STERILIZATION WRAP

K140963 is an FDA 510(k) clearance for KIMGUARD SMART-FOLD STERILIZATION WRAP, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K140963 · Kimberly-Clark Corp. · General Hospital
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Nov 2014
Decision
209d
Days
Class 2
Risk

K140963 is an FDA 510(k) clearance for the KIMGUARD SMART-FOLD STERILIZATION WRAP. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on November 10, 2014 after a review of 209 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 Corp. devices

FDA 510(k) Submission Details - K140963

510(k) Number K140963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2014
Decision Date November 10, 2014
Days to Decision 209 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
80d slower than avg
Panel avg: 129d · This submission: 209d
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 141
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K140963.
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
VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
K140487 · STERIS Corporation · Jul 2014
DURABLUE STERILIZATION WRAP
K130927 · Cardinal Health200, LLC · Jun 2013
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013