# K240286: PRIMED Surgical Masks and PRIMED Procedure Masks

- Pathway: 510(k) (Traditional)
- Applicant: Primed Medical Products, Inc.
- Decided: Aug 26, 2024 after 207 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: 2 generations back to K001951 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081633: Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks, Primed Medical Products, Inc. (2008) Summary page 5.

## Most influential descendants
- K252964: PRIMED Surgical and Procedure Masks (2025), 0 descendants of its own

## Indications for use
PRIMED Surgical Masks and PRIMED Procedure Masks are single use, non-sterile products intended to be worn by operating room and health care personnel in health care setting and during surgical procedures to protect both the patient and the operating room personnel from transfer of microorganisms, body fluids and particulate materials.

Source page: https://510kreport.com/device/K240286
Methodology: https://510kreport.com/methodology