# K202029: Medical Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
- Decided: Dec 16, 2020 after 147 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 K970835 (1997). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), V&Q Manufacturing Corporation (2018) Summary page 5.

## Most influential descendants
- K212649: Disposable Surgical Face Mask (2022), 0 descendants of its own
- K210518: Surgical Face Mask (2021), 0 descendants of its own

## Indications for use
The medical surgical mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Source page: https://510kreport.com/device/K202029
Methodology: https://510kreport.com/methodology