510(k) K191027 ยท BSZ Gas-Machine, Anesthesia
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
| Applicant | Maquet Critical Care AB, Solna, SE |
| Decision | Substantially Equivalent, Mar 18, 2020 |
| Received | Apr 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Maquet Critical Care AB Flow Anesthesia Machine
Flow-i C20 6677200
Flow-i C30 6677300
Flow-i C40 6677400
Flow-i C20 6888520
Flow-i C30 6888530
Flow-i C40 6888540
Flow-c 6887700
Flow-e 6887900 Open, Classified |
BSZ | None listed |
| Feb 7, 2025 | Getinge Usa Sales Inc Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia. Open, Classified |
BSZ | None listed |
| May 31, 2024 | Getinge Usa Sales Inc Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e. Open, Classified |
BSZ | None listed |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-i Anesthesia Systems
Flow-i C20, Part no. 6677200
Flow-i C30, Part no. 6677300
Flow-i C40, Part no. 6677400 Open, Classified |
BSZ | None listed |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-c Anesthesia System, Part No. 6887700 Open, Classified |
BSZ | None listed |
| Jan 26, 2023 | Getinge Usa Sales Inc Getinge Flow-e Anesthesia System, Part No. 6887900 Open, Classified |
BSZ | None listed |
| Dec 7, 2022 | Getinge Usa Sales Inc Flow-c Anesthesia System (Product Code 6887700)
Flow-e Anesthesia System (Product Code 6887900) Open, Classified |
BSZ | None listed |
| Jun 23, 2022 | Getinge Usa Sales Inc Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient
Product Code/REF Number: 6887700 Terminated |
BSZ | None listed |
| Jun 23, 2022 | Getinge Usa Sales Inc Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient
Product Code/REF Number: 6887900 Terminated |
BSZ | None listed |
| Dec 9, 2021 | Getinge Usa Sales Inc Vaporizer Sevoflurane Maquet Filling, Part No. 6886601
Component of the following systems:
Product Code(s) UPN/UDI:
Flow-c Anesthesia System 6887700 07325710009765
Flow-e Anesthesia System 6887900 0 Open, Classified |
BSZ | None listed |
| Jan 29, 2021 | Getinge Group Logistics America, LLC Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients Terminated |
BSZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.