# K202463: Disposable Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Unisources Group, LLC
- Decided: Sep 18, 2020 after 22 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: 9 generations back to K874608 (1987). 11 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182515: Surgical Face Mask, Wuhan Dymex Healthcare Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K220378: Sparta 3-Ply Surgical Disposable Face Mask (2022), 0 descendants of its own
- K211165: Medical Face Masks, Model Name:MY020003 (2021), 0 descendants of its own
- K210348: Disposable Medical Surgical Mask (2021), 0 descendants of its own
- K211249: Altor Safety 3-Ply Surgical Mask (Model:62222) (2021), 0 descendants of its own

## Indications for use
The Disposable Surgical Mask, FILTECH M201 is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. The disposable surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K202463
Methodology: https://510kreport.com/methodology