# K040642: Lpo Option for Drager Intensive Care Ventilator Savina

- Pathway: 510(k) (Special)
- Applicant: Draeget Medical AG & Co. Kgaa
- Decided: Jun 2, 2004 after 83 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883038 (1988). 11 ancestors in all.
15 later devices descend from it; 1 cites it directly.
7 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072, Drager Medizintechnik GmbH (2003) Summary page 1.
- K020746: Bird Tbird Vela Ventilator, Bird Products Corp. (2002) Summary page 1.

## Most influential descendants
- K102775: Hamilton-C2 (2011), 14 descendants of its own
- 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

## Indications for use
Long-term ventilator for intensive care. For patient requiring tidal volume starting at 50 ml.

Source page: https://510kreport.com/device/K040642
Methodology: https://510kreport.com/methodology