Cleared Traditional

PRIMED Surgical Masks and PRIMED Procedure Masks (K240286) - FDA 510(k) Clearance

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

K240286 · Primed Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
207d
Days
Class 2
Risk

K240286 is an FDA 510(k) clearance for the PRIMED Surgical Masks and PRIMED 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 August 26, 2024 after a review of 207 days - an extended review 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: 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 Primed Medical Products, Inc. devices

Submission Details

510(k) Number K240286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date August 26, 2024
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
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 K240286.
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · Owens & Minor (O&M) Halyard, Inc. · May 2025
Aurelia Surgical Mask ASTM Level-3 (2130)
K242502 · Supermax Healthcare Canada-Supermax Medical · Nov 2024
Surgical Face Mask (Tie on/ Ear loops)
K240916 · Xiantao Daoqi Plastic Co., Ltd. · Oct 2024
Medical surgical mask
K233723 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Jul 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802)
K232824 · Owens & Minor (O&M) Halyard, Inc. · Jul 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)
K232777 · Owens & Minor (O&M) Halyard, Inc. · Jul 2024