# K961687: EVITA 4

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Dec 13, 1996 after 226 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 K902859 (1991). 3 ancestors in all.
211 later devices descend from it; 11 cite it directly.
57 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924930: EVITA, Drager, Inc. (1994) Summary page 1.
- K942849: Capnosat, Spegas Industries, Ltd. (1995). Our OCR of the scanned summary read K922849, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Drager Capnosat”.
- K902859: Servo Ventilator 300, Siemens Life Support Systems (1991) Summary page 1.

## Most influential descendants
- K970460: Nellcor Puritan Bennett, 840 Ventilator System (Model 840) (1998), 174 descendants of its own
- K970165: Evita 2 Dura (1997), 140 descendants of its own
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own

Source page: https://510kreport.com/device/K961687
Methodology: https://510kreport.com/methodology