# K180874: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Jul 31, 2018 after 119 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: 6 generations back to K874608 (1987). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143287: Fluidshield* Surgical Mask with Expanded Chamber, Halyard Health, Inc. (2015) Summary page 4.

## Most influential descendants
- K210445: Nordiwell Surprotect Face Mask (2021), 1 descendant of its own
- K211497: Surgical Mask (2021), 0 descendants of its own

## Indications for use
The 3M™ High Performance Surgical Mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face mask(s) are intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device(s) and provided non-sterile.

Source page: https://510kreport.com/device/K180874
Methodology: https://510kreport.com/methodology