# K112114: Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Jan 13, 2012 after 172 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930017 (1994). 35 ancestors in all.
3 later devices descend from it; 1 cites it directly.
4 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102182: Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30, Maquet Critical Care AB (2011) Summary page 3.
- K090233: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc. (2009) Summary page 1.

## Most influential descendants
- K133958: Flow-I Anesthesia System C20, C30 & C40 (2014), 2 descendants of its own
- K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (2017), 1 descendant of its own
- K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (2020), 0 descendants of its own

## Recalls of this device
- Feb 20, 2012 · Class I · Z-1925-2012: A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engag

## Indications for use
The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRIf environment, by healthcare professionals trained in inhalation Anesthesia administration.

Source page: https://510kreport.com/device/K112114
Methodology: https://510kreport.com/methodology