Cleared Traditional

K141712 - KIMGUARD ONE STEP STERILIZATION WRAP (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141712 · Halyard Health · General Hospital
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 169d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K141712.
Sterilization Pouch/Roll
K251347 · Sterivic Medical Co., Ltd. · Jan 2026
Self-Seal Sterilization Pouch and Roll
K251177 · Guangdong Maidi Medical Co., Ltd. · Dec 2025
Chex-All Sterilization Pouches and Tubes
K250306 · Propper Manufacturing Co., Inc. · Oct 2025
Sterilization Pouch and Roll
K243179 · Yichang Xinxin Paper Products Co., Ltd. · Jun 2025
GCI Sterilization Wrappers
K250321 · George Courey, Inc. · Jun 2025
Self Sealing Sterilization Pouches
K243721 · Wellmed Dental Medical Supply Co., Ltd. · Apr 2025