Cleared Traditional

PRIMED Surgical and Procedure Masks (K252964) - FDA 510(k) Clearance

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

K252964 · Primed Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
48d
Days
Class 2
Risk

K252964 is an FDA 510(k) clearance for the PRIMED Surgical and Procedure Masks. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Primed Medical Products, Inc. (Edmonton, CA). The FDA issued a Cleared decision on November 4, 2025 after a review of 48 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 Primed Medical Products, Inc. devices

Submission Details

510(k) Number K252964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2025
Decision Date November 04, 2025
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
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.

Regulatory Peers - FXX Mask, Surgical

All 404
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K252964.
Disposable Medical Face Mask
K252650 · Makrite Industries, Inc. · Jan 2026
KP Protective Face Mask
K243342 · Kp Trading Co., Ltd. · Dec 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · O&M Halyard, Inc. · Dec 2025
Vitaform Procedural Mask - Blue (Vitaform Blue)
K251902 · Vitacore Industries, Inc. · Sep 2025
Procedure mask/Surgical mask/Face mask
K250082 · Winner Medical Co., Ltd. · Jun 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · Owens & Minor (O&M) Halyard, Inc. · May 2025