# K221634: Oxymag - Transport and Emergency Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Magnamed Tecnologia Medica S/A
- Decided: May 24, 2023 after 352 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: 7 generations back to K962603 (1997). 24 ancestors in all.
No later device cites it as a predicate yet.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141595: O-Two E700,O-Two E600,O-Two E500, O-Two Medical Technologies, Inc. (2015) Summary page 4.

## Indications for use
Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support. It is intended for pre-hospital and hospital use including intra-hospital, inter-hospital and transport settings.

Source page: https://510kreport.com/device/K221634
Methodology: https://510kreport.com/methodology