# K082600: Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical B.V.
- Decided: Nov 26, 2008 after 79 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 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). 16 ancestors in all.
3 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 1.
- K062267: Oxylog 3000, Drager Medical B.V. (2006) Summary page 1.

## Most influential descendants
- K103625: Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic Device (2011), 2 descendants of its own
- 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
- 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

## Indications for use
The Oxylog 2000 plus is a time-cycled, volume controlled emergency and transport ventilator with pressure support for patients requiring mandatory or assisted ventilation with a tidal volume from 100 mL upwards.

Source page: https://510kreport.com/device/K082600
Methodology: https://510kreport.com/methodology