# K141595: O-Two E700,O-Two E600,O-Two E500

- Pathway: 510(k) (Traditional)
- Applicant: O-Two Medical Technologies, Inc.
- Decided: Mar 16, 2015 after 276 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062267: Oxylog 3000, Drager Medical B.V. (2006) Summary page 4.
- K081330: Carevent Par (Public Access Resuscitator), O-Two Medical Technologies, Inc. (2009) Summary page 4.

## Most influential descendants
- K221634: Oxymag - Transport and Emergency Ventilator (2023), 0 descendants of its own

## Recalls of this device
- Feb 12, 2019 · Class I · Z-0976-2019: There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it 
- Feb 12, 2019 · Class I · Z-0978-2019: There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it 
- Feb 12, 2019 · Class I · Z-0977-2019: There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it 

## Indications for use
o_two e700, e600 and e500 are a time-cycled, volume-constant and pressure-controlled (only e700) emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child, infant patients with a tidal volume from 50 ml (100 ml for e500) upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require ventilatory support.

Source page: https://510kreport.com/device/K141595
Methodology: https://510kreport.com/methodology