Cleared Traditional

K234050 - HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (FDA 510(k) Clearance)

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

K234050 · O&M Halyard, Inc. · General Hospital

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Sep 2024

Decision

270d

Days

Class 2

Risk

K234050 is an FDA 510(k) clearance for the HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wr.... Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on September 16, 2024 after a review of 270 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 O&M Halyard, Inc. devices

Submission Details

510(k) Number	K234050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 21, 2023
Decision Date	September 16, 2024
Days to Decision	270 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

142d slower than avg

Panel avg: 128d · This submission: 270d

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.