# K953414: CPR Micromask with Oxygen Inlet

- Pathway: 510(k) (Traditional)
- Applicant: Plasco, Inc.
- Decided: Mar 20, 1996 after 244 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
Longest line of descent: 1 generation back to K861401 (1986). 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)
- K861401: Laerdal Pocket Mask, Laerdal Medical Corp. (1986) Summary page 1.

## Indications for use
A device used for mouth-to-mask treatment of respiratory failure.

Source page: https://510kreport.com/device/K953414
Methodology: https://510kreport.com/methodology