# K980066: CPR Filtershield

- Pathway: 510(k) (Traditional)
- Applicant: Plasco, Inc.
- Decided: Jul 16, 1998 after 190 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880450 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880450: Resusci Patient Face Shield, Laerdal Medical Corp. (1988) Summary page 1.

## Indications for use
The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques.

Source page: https://510kreport.com/device/K980066
Methodology: https://510kreport.com/methodology