Cleared Traditional

K113806 - KIMGUARD ONE STEP STERILIZATION WRAP

K113806 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 606-day FDA review.

K113806 · Kimberly-Clark Health Care · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
606d
Days
Class 2
Risk

K113806 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 (Irvin, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 606 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Kimberly-Clark Health Care devices

FDA 510(k) Submission Details - K113806

510(k) Number K113806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2011
Decision Date August 20, 2013
Days to Decision 606 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
477d slower than avg
Panel avg: 129d · This submission: 606d
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 K113806.
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
DURABLUE STERILIZATION WRAP
K130927 · Cardinal Health200, LLC · Jun 2013
GEMINI STERILZATION WRAP
K113353 · Medline Industries, Inc. · Jan 2013
DURABLUE STERILIZATION WRAP
K123857 · Cardinal Health200, LLC · Jan 2013