# K201844: Surgical Face Mask, Surgical Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Lear Corporation
- Decided: Jul 14, 2021 after 373 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: 7 generations back to K970835 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201479: DemeMASK, Demetech Corporation (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

Source page: https://510kreport.com/device/K201844
Methodology: https://510kreport.com/methodology