# K031400: Fabius Tiro Anesthesia System

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical, Inc.
- Decided: Jul 15, 2003 after 71 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: 1 generation back to K000859 (2000). 2 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K011404: Fabius GS Anesthesia System, Model Fabius GS, Draeger Medical, Inc. (2002)
- K000859: Office Based Anesthesia Machine, Model Oba-1, Charles A. Smith (2000) Summary page 2.

## 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 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/K031400
Methodology: https://510kreport.com/methodology