# K010093: Non-Invasive Ventilation Niv Option, Model 84 14 474

- Pathway: 510(k) (Traditional)
- Applicant: Drager Medizintechnik GmbH
- Decided: Jun 14, 2001 after 154 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
95 later devices descend from it; 6 cite it directly.
30 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own
- K051263: Evitaxl with Option Smartcare (2005), 51 descendants of its own
- K081842: Engstrom Carestation, Engstrom Pro (2008), 37 descendants of its own

## Recalls of this device
- Jul 2, 2008 · Not classified · Z-2325-2008: Audible power failure alarm was not enunciated at the required volume
- Jul 2, 2008 · Not classified · Z-2326-2008: audible power failure alarm was not enunciated at the required volume
- May 7, 2003 · Not classified · Z-0954-03: software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.

Source page: https://510kreport.com/device/K010093
Methodology: https://510kreport.com/methodology