# K252964: PRIMED Surgical and Procedure Masks

- Pathway: 510(k) (Traditional)
- Applicant: Primed Medical Products, Inc.
- Decided: Nov 4, 2025 after 48 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001951 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240286: PRIMED Surgical Masks and PRIMED Procedure Masks, Primed Medical Products, Inc. (2024) Summary page 6.

## Indications for use
PRIMED Surgical masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings and during surgical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials. PRIMED Procedure Masks are single use, non-sterile, disposable products intended to be worn by healthcare personnel in healthcare settings to protect both the patient and healthcare personnel from transfer of microorganisms, body fluid and particulate materials.

Source page: https://510kreport.com/device/K252964
Methodology: https://510kreport.com/methodology