# K991955: Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2 Detection

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Jul 6, 1999 after 35 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: 3 generations back to K894053 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912203: Ems Single Use Manual Resuscitators, Engineered Medical Systems (1991) Summary page 1.
- K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit, Engineered Medical Systems (1993) Summary page 1.
- K973419: DMR Plus Disposable Manual Resuscitator, Nellcor Puritan Bennett, Inc. (1998) Summary page 1.
- K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector, Fenem, Inc. (1989) Summary page 1.
- K944400: Pedi-Cap, Nellcor, Inc. (1994) Summary page 1.

## Indications for use
Disposable manual resuscitator with CO₂ detection for use with patients requiring manual ventilatory support. The CO₂ detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO₂ detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO₂ detector detects approximate ranges of CO₂ by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

Source page: https://510kreport.com/device/K991955
Methodology: https://510kreport.com/methodology