# K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical, Inc.
- Decided: Jul 8, 2004 after 22 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: 4 generations back to K901713 (1990). 15 ancestors in all.
14 later devices descend from it; 2 cite it directly.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030624: Modification to Fabius GS Anesthesia System, Draeger Medical, Inc. (2004) Summary page 1.
- K031400: Fabius Tiro Anesthesia System, Draeger Medical, Inc. (2003) Summary page 1.
- K033498: Narkomed 6400, Model NM6400, Draeger Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K133886: Perseus A500 (2014), 2 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. The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic 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/K041622
Methodology: https://510kreport.com/methodology