Cleared Traditional

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap (K214007) - FDA 510(k) Clearance

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

K214007 · Owens & Minor (O&M) Halyard, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
217d
Days
Class 2
Risk

K214007 is an FDA 510(k) clearance for the HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on July 27, 2022 after a review of 217 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 (O&M) Halyard, Inc. devices

Submission Details

510(k) Number K214007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date July 27, 2022
Days to Decision 217 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
88d slower than avg
Panel avg: 129d · This submission: 217d
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 89
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K214007.
Gemini Sterilization Wrap
K220365 · Medline Industries, LP · Oct 2022
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
K222440 · Steris · Sep 2022
Solidence Multipockets
K191131 · Solidence Surgical Corporation · Aug 2022
Steriking Packaging for Medical Devices
K221016 · Wipak OY · May 2022
CareGUARD Sterilization Wrap
K213907 · Care Essentials Pty, Ltd. · Mar 2022
Sterilization Wraps
K220133 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · Mar 2022