# K030624: Modification to Fabius GS Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Mar 17, 2004 after 384 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
Longest line of descent: 2 generations back to K902859 (1991). 5 ancestors in all.
15 later devices descend from it; 1 cites it directly.
4 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011404: Fabius GS Anesthesia System, Model Fabius GS, Draeger Medical, Inc. (2002) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own

## Indications for use
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K030624
Methodology: https://510kreport.com/methodology