# K042086: Fabius GS Anesthesia System; Fabius Tiro Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Aug 31, 2004 after 28 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: 5 generations back to K901713 (1990). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041622: Modification to Fabius GS Anesthesia System; Fabius Tiro Anesthesia System, Draeger Medical, Inc. (2004) Summary page 1.
- K961687: EVITA 4, Drager, Inc. (1996) Summary page 1.
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Most influential descendants
- K042419: Fabius GS/Fabius Tiro Anesthesia System (2004), 1 descendant of its own
- K072884: Fabius Mri (2008), 0 descendants of its own

## Indications for use
The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius Tiro 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 these devices to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K042086
Methodology: https://510kreport.com/methodology