PRIMED Surgical and Procedure Masks— 510(k) K252964

Substantially Equivalent

Primed Medical Products, Inc.

FDA 510(k) clearance K252964 for PRIMED Surgical and Procedure Masks, Substantially Equivalent on 2025-11-04. Applicant: Primed Medical Products, Inc..

Clearance details

Applicant: Primed Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2025-09-17
Decision date: 2025-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edmonton, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.