Cleared Traditional

K252941 - HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (FDA 510(k) Clearance)

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

K252941 · O&M Halyard, Inc. · General Hospital

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Dec 2025

Decision

87d

Days

Class 2

Risk

K252941 is an FDA 510(k) clearance for the HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on December 11, 2025 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number	K252941 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 15, 2025
Decision Date	December 11, 2025
Days to Decision	87 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

41d faster than avg

Panel avg: 128d · This submission: 87d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FXX Mask, Surgical
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4040

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.