# K103625: Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Oct 6, 2011 after 300 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984577: Drager Oxylog 2000, Drager, Inc. (1999) Summary page 2.
- K062267: Oxylog 3000, Drager Medical B.V. (2006) Summary page 2.
- K082600: Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082), Draeger Medical B.V. (2008) Summary page 2.

## Most influential descendants
- K121886: Savina 300 Savina 300, Country Variants (2014), 1 descendant of its own
- K180779: Savina 300 (2019), 0 descendants of its own

## Recalls of this device
- Jun 12, 2023 · Class I · Z-2018-2023: Draeger has become aware of instances where the device stopped working when in use when transitioning from battery to AC operation.
- Dec 22, 2015 · Class I · Z-0692-2016: Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops o
- Dec 22, 2015 · Class I · Z-0691-2016: Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops o
- Mar 5, 2014 · Class I · Z-1440-2014: The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplu

## Indications for use
The Oxylog 3000 plus is a time-cycled, volume controlled and pressure controlled emergency and transport ventilator for patients requiring mandatory or assisted ventilation with a tidal volume from 50 mL upwards.

Source page: https://510kreport.com/device/K103625
Methodology: https://510kreport.com/methodology