# K210256: CiRx (R) Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Shun YE Medical Company, Ltd.
- Decided: Aug 19, 2021 after 199 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: 5 generations back to K970835 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122717: Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask, Tiger Medical Products, Ltd. (2012) Summary page 6.

## Indications for use
This device 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 fluid, and particulate materials.

Source page: https://510kreport.com/device/K210256
Methodology: https://510kreport.com/methodology