# K023289: Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072

- Pathway: 510(k) (Special)
- Applicant: Drager Medizintechnik GmbH
- Decided: Jan 15, 2003 after 105 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: 1 generation back to K010093 (2001). 2 ancestors in all.
17 later devices descend from it; 2 cite it directly.
7 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474, Drager Medizintechnik GmbH (2001) Summary page 1.
- K003068: Savina, Drager Medizintechnik GmbH (2001) Summary page 1.

## Most influential descendants
- K040642: Lpo Option for Drager Intensive Care Ventilator Savina (2004), 15 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K023289
Methodology: https://510kreport.com/methodology