# K983705: Emt Resuscitator

- Pathway: 510(k) (Special)
- Applicant: O-Two Systems Intl., Inc.
- Decided: Oct 29, 1998 after 8 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- 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 K932170 (1993). 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)
- K932170: Flynnr Genesis II a/C, a/O and Idlh, O-Two Systems Intl., Inc. (1993) Summary page 1.

## Indications for use
Pulmonary resuscitation during respiratory and/or cardiac arrest. Short term ventilatory support for both inter and intra-hospital transport of non-breathing patients.

Source page: https://510kreport.com/device/K983705
Methodology: https://510kreport.com/methodology