# K192285: CPR Face Shield

- Pathway: 510(k) (Traditional)
- Applicant: Firstar Healthcare Company Limited (Guangzhou)
- Decided: Nov 25, 2020 after 461 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is used as a physical barrier for mouth to mouth resuscitation. The use of this device does not guarantee complete protection from disease transmission.

Source page: https://510kreport.com/device/K192285
Methodology: https://510kreport.com/methodology