Cleared Traditional

K181959 - HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) (FDA 510(k) Clearance)

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

K181959 · Owens & Minor Halyard, Inc. · General Hospital
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.

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
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 169d · 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 12
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K181959.
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