# K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Mar 18, 2020 after 335 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 11 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K930017 (1994). 38 ancestors in all.
No later device cites it as a predicate yet.
4 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160665: FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40, Maquet Critical Care AB (2017) Summary page 5.

## Recalls of this device
- Jun 24, 2026 · Class II · Z-2860-2026: Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may l
- Jan 15, 2025 · Class I · Z-1074-2025: Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include i
- May 1, 2024 · Class I · Z-1877-2024: Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include i
- Dec 22, 2022 · Class I · Z-0959-2023: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hyp
- Dec 22, 2022 · Class I · Z-0961-2023: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hyp
- Dec 22, 2022 · Class I · Z-0960-2023: Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hyp
- Nov 7, 2022 · Class II · Z-0422-2023: The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event 
- May 2, 2022 · Class I · Z-1279-2022: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction u
- May 2, 2022 · Class I · Z-1278-2022: Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can break, preventing the suction u
- Dec 9, 2021 · Class I · Z-0468-2022: A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of hydrogen fluoride.
- Jan 29, 2021 · Class II · Z-1181-2021: Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anes

## Indications for use
The indication for Flow-i/Flow-c/Flow-e 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/K191027
Methodology: https://510kreport.com/methodology