# K221957: Savewo ClassicMASK

- Pathway: 510(k) (Traditional)
- Applicant: Savewo Limited
- Decided: Sep 2, 2022 after 59 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.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200923: Single-use Surgical Mask, Byd Precision Manufacturer Co., Ltd. (2020) Summary page 4.

## Indications for use
Savewo ClassicMASKs are intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. Savewo ClassicMASKs are 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) and provided non-sterile.

Source page: https://510kreport.com/device/K221957
Methodology: https://510kreport.com/methodology