Cleared Traditional

K181959 - HALYARD SMART-FOLD* Sterilization Wrap ...

K181959 is the FDA 510(k) clearance for HALYARD SMART-FOLD* Sterilization Wrap ... by Owens & Minor Halyard, Inc.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K181959 · Owens & Minor Halyard, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
242d
Days
Class 2
Risk

K181959 is an FDA 510(k) clearance for the HALYARD SMART-FOLD* Sterilization Wrap (H450, H650). Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Owens & Minor Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 22, 2019 after a review of 242 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 Owens & Minor Halyard, Inc. devices

Submission Details

510(k) Number K181959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date March 22, 2019
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 122
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K181959.
Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
K183356 · Weihai Xingtai Packaging Products Co., Ltd. · Aug 2019
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
K181957 · Tianchang Jiarui Packaging Material Co., Ltd. · Jul 2019
JAMBRO Single Core A Sterilization wrap
K182656 · Jiangsu Zhande Medical Supplies Co., Ltd. · Jun 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183401 · STERIS Corporation · Mar 2019
Safe Secure Sterilization Pouches and Rolls
K180139 · Safe Secure Packing Co., Ltd. · Jan 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183297 · STERIS Corporation · Jan 2019