Cleared Traditional

K141712 - KIMGUARD ONE STEP STERILIZATION WRAP

K141712 is an FDA 510(k) clearance for KIMGUARD ONE STEP STERILIZATION WRAP, manufactured by Halyard Health. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K141712 · Halyard Health · General Hospital
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Dec 2014
Decision
176d
Days
Class 2
Risk

K141712 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 Halyard Health (Minneapolis, US). The FDA issued a Cleared decision on December 18, 2014 after a review of 176 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 Halyard Health devices

FDA 510(k) Submission Details - K141712

510(k) Number K141712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2014
Decision Date December 18, 2014
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 K141712.
STERILIZATION POUCH/ROLL MADE WITH TYVEK
K133838 · Sigma Medical Supplies Corp. · Mar 2015
KIMGUARD ONE-STEP Sterilization Wrap
K142782 · Kimberly-Clark Health Care · Mar 2015
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · Advanced Sterilization Products · Dec 2014
STERILUCENT SELF-SEAL STERILIZATION POUCH
K141412 · Gs Medical Packaging, Inc. · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014
KIMGUARD ONE-STEP STERILIZATION WRAP
K141612 · Kimberly-Clark Health Care · Aug 2014