# K062267: Oxylog 3000

- Pathway: 510(k) (Traditional)
- Applicant: Drager Medical B.V.
- Decided: Oct 31, 2006 after 88 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 15 ancestors in all.
20 later devices descend from it; 5 cite it directly.
11 of 36 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.
- K040790: Modification to LTV 1000 Ventilator/Breathing Circuits, Pulmonetic Systems, Inc. (2004) Summary page 2.
- K003068: Savina, Drager Medizintechnik GmbH (2001) Summary page 2.
- K942938: Crossvent-4 Ventilator, Bio-Med Devices, Inc. (1995) Summary page 2.
- K042468: Ivent 201 Portable Ventilator, Versamed Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K112006: Hamilton-TC1 (2012), 13 descendants of its own
- K120670: Hamilton-T1 (2012), 11 descendants of its own
- K121225: Hamilton-C2 (2012), 8 descendants of its own
- K123637: Hamilton-C3 (2012), 4 descendants of its own
- K161450: Hamilton-C3 (2017), 3 descendants of its own

## Recalls of this device
- May 31, 2016 · Class I · Z-2215-2016: Isolated episodes of leakage at the check valve were found
- 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
- Aug 19, 2010 · Not classified · Z-0018-2011: Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
- Oct 3, 2008 · Not classified · Z-0202-2009: May experience an interruption of ventilation for approximately 5 seconds

## Indications for use
Oxylog 3000 is a time-cycled, volume-constant and pressure controlled emergency and transport ventilator for patients with a tidal volume from 50 mL upwards.

Source page: https://510kreport.com/device/K062267
Methodology: https://510kreport.com/methodology