Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System— 510(k) K191027
Substantially EquivalentMaquet Critical Care AB
FDA 510(k) clearance K191027 for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System, Substantially Equivalent on 2020-03-18. Applicant: Maquet Critical Care AB. Device class: 2.
Clearance details
- Applicant
- Maquet Critical Care AB
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Solna, SE
Recent devices under product code BSZ
view allMore clearances from Maquet Critical Care AB
view all- K253715 — Edi Catheter ENFit 6Fr/48 cm (6893166) +7 more
- K230173 — Servo-air Lite Ventilator System
- K201874 — Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
- K182862 — Servo Guard
- K180098 — SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K191027
K-number listed on FDA's recall record- Z-2860-2026 — 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
- Z-1074-2025 — 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.
- Z-1877-2024 — Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
- Z-0959-2023 — Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
- Z-0960-2023 — Getinge Flow-c Anesthesia System, Part No. 6887700
- Z-0961-2023 — Getinge Flow-e Anesthesia System, Part No. 6887900
- Z-0422-2023 — Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
- Z-1278-2022 — Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
- Z-1279-2022 — Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
- Z-0468-2022 — 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 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i Anesthesia System C30 6888530 07325710010624 Flow-i Anesthesia System C40 6888540 07325710010631 Flow-i C20 Anesthesia System 6677200 07325710001349 Flow-i C30 Anesthesia System 6677300 07325710001349 Flow-i C40 Anesthesia System 6677400 07325710001318
- Z-1181-2021 — 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 with limited ability to breathe.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.