# K201137: Asept Surgical Face Mask

- Pathway: 510(k) (Abbreviated)
- Applicant: Pfm Medical, Inc.
- Decided: Aug 19, 2020 after 113 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 K874608 (1987). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111559: Surgical Masks, Shanghai Neo-Medical Import & Export Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K203200: Disposable Medical Surgical Face Mask (2021), 1 descendant of its own
- K210643: Disposable Surgical Face Mask (2021), 0 descendants of its own
- K203174: Disposable Medical Mask (2021), 0 descendants of its own

## Indications for use
The ASEPT® Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Source page: https://510kreport.com/device/K201137
Methodology: https://510kreport.com/methodology