# K011404: Fabius GS Anesthesia System, Model Fabius GS

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Feb 22, 2002 after 290 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
4 of 18 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
- K030624: Modification to Fabius GS Anesthesia System (2004), 15 descendants of its own
- K031400: Fabius Tiro Anesthesia System (2003), 15 descendants of its own
- K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System (2004), 14 descendants of its own
- K042607: Primus US (2004), 10 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own

Source page: https://510kreport.com/device/K011404
Methodology: https://510kreport.com/methodology