# K083418: CPR Mask

- Pathway: 510(k) (Traditional)
- Applicant: Firstar Healthcare Co., Ltd.
- Decided: Jul 22, 2010 after 611 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861401 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081516: Medsource CPR Mask with & Without Oxygen Port, Medsource International, LLC (2008) Summary page 1.
- K042727: Pocket Size Resuscitator/Model: M16201R and M16201A, Foremount Ent. Co., Ltd. (2005) Summary page 1.

## Recalls of this device
- May 16, 2016 · Class II · Z-2133-2016: Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-co
- May 16, 2016 · Class II · Z-2132-2016: First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for o

## Indications for use
The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use. The FS-104 CPR mask with oxygen port is intended for single use only.

Source page: https://510kreport.com/device/K083418
Methodology: https://510kreport.com/methodology