# K980208: Divan Anesthesia Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Aug 4, 1998 after 196 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 K953228 (1996). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953228: Narkomed AV2+ Anesthesia Ventilator, Draeger Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K983635: Julian Anesthesia Workstation, Model # Julian (1999), 11 descendants of its own
- K042607: Primus US (2004), 10 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own

## Indications for use
The Divan is indicated for ventilating patients as an integrated part of specific North American Driger anesthesia machines. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K980208
Methodology: https://510kreport.com/methodology