# K042419: Fabius GS/Fabius Tiro Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: Oct 8, 2004 after 31 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 11 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K901713 (1990). 22 ancestors in all.
1 later device descends 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)
- K042086: 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
- K072884: Fabius Mri (2008), 0 descendants of its own

## Recalls of this device
- May 24, 2018 · Class II · Z-2251-2018: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to t
- May 24, 2018 · Class II · Z-2250-2018: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to t
- Mar 1, 2018 · Class I · Z-1484-2018: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Mar 1, 2018 · Class I · Z-1482-2018: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Mar 1, 2018 · Class I · Z-1483-2018: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
- Aug 14, 2013 · Class I · Z-0008-2014: During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical com
- Aug 26, 2010 · Not classified · Z-2479-2010: potential failures to Electri-Cord Manufacturing AC power cord
- Aug 26, 2010 · Not classified · Z-2478-2010: potential failures to Electri-Cord Manufacturing AC power cord
- Jul 7, 2008 · Not classified · Z-2338-2008: The parent company became aware of instances where the lower side rail of the frame of the machine broke inwards when being moved across a threshold; resulting in the machine being unstable.
- Feb 5, 2008 · Not classified · Z-1315-2008: Detachment of Component: The chassis on some machines were manufactured out of specifications. As a result, the caster may break loose from the chassis.
- Oct 3, 2006 · Not classified · Z-0048-2007: One of four casters may break loose from chassis

## Indications for use
The Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent 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/K042419
Methodology: https://510kreport.com/methodology