# K133958: Flow-I Anesthesia System C20, C30 & C40

- Pathway: 510(k) (Abbreviated)
- Applicant: Maquet Critical Care AB
- Decided: Mar 20, 2014 after 86 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 8 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930017 (1994). 36 ancestors in all.
2 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)
- K112114: Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40, Maquet Critical Care AB (2012) Summary page 2.

## Most influential descendants
- 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
- Dec 11, 2023 · Class II · Z-0991-2024: Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead t
- Dec 11, 2023 · Class II · Z-0987-2024: Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead t
- Dec 11, 2023 · Class II · Z-0988-2024: Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead t
- Dec 11, 2023 · Class II · Z-0989-2024: Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead t
- Dec 11, 2023 · Class II · Z-0990-2024: Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead t
- Dec 10, 2015 · Class I · Z-0804-2016: Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-sy
- Apr 2, 2015 · Class I · Z-1706-2015: In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
- Mar 2, 2015 · Class II · Z-2083-2015: Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a d

## Indications for use
The indication for IFLOW-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 atlimited 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 MIRI environment, by healthcare professionals trained in inhalation Anesthesia administration.

Source page: https://510kreport.com/device/K133958
Methodology: https://510kreport.com/methodology