# K983919: Ems Mouth to Mask Resuscitators

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Apr 7, 1999 after 154 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 K871407 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881086: Lifeguard Mouth to Mask Resuscitator, Lifeguard Medical Products, Inc. (1988) Summary page 1.
- K953230: CPR Super Pocket Pack, Formosa-Cj Health Business Corp. (1996) Summary page 1.
- K871407: Meconium Aspirator, Intertech Resources, Inc. (1987) Summary page 1.

## Most influential descendants
- K171961: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) (2017), 0 descendants of its own

## Indications for use
Indicated to provide assisted ventilation to someone requiring assisted ventilation, breathing or resuscitation, by use of a mouth to mask method. Patient population is child / infant and adult. Those with oxygen port are prescription devices and those without the oxygen port are OTC.

Source page: https://510kreport.com/device/K983919
Methodology: https://510kreport.com/methodology