# K201549: Motex Anti-Fog Surgical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Modern Healthcare Corp.
- Decided: Aug 26, 2020 after 78 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: 4 generations back to K970835 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063043: Surgical Face Mask, Type: Tie-on, Ear-Loop, Modern Healthcare Corp. (2007) Summary page 4.

## Most influential descendants
- K212863: Surgical Face Mask (2022), 0 descendants of its own

## Indications for use
The Motex Anti-Fog Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Source page: https://510kreport.com/device/K201549
Methodology: https://510kreport.com/methodology