# K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

- Pathway: 510(k) (Abbreviated)
- Applicant: Maquet Critical Care AB
- Decided: Mar 29, 2017 after 385 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: 11 generations back to K930017 (1994). 37 ancestors in all.
1 later device descends 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)
- K133958: Flow-I Anesthesia System C20, C30 & C40, Maquet Critical Care AB (2014) Summary page 5.

## Most influential descendants
- K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (2020), 0 descendants of its own

## 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 MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Source page: https://510kreport.com/device/K160665
Methodology: https://510kreport.com/methodology