510(k) · Cleared
Recalled · Class I · 2026Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Critical Care AB · BSZ Gas-Machine, Anesthesia
Cleared on Mar 18, 2020 as substantially equivalent to K160665 (Maquet Critical Care AB, 2017) after a 335-day review. Its family tree reaches back 12 generations to 1994. 4 of the 39 devices in its family, counting itself, have a Class I recall. It has been recalled 11 times, including 8 Class I recalls.
- Decided
- Mar 18, 2020
- Review
- 335 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 11 (8 Class I)
- Predicates
- 1
Its longest line of descent runs back 12 generations to K930017 (1994). 38 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 4 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 8 generations between
- 3 generations backK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
- 2 generations backK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
- 1 generation backK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017
- This deviceK191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e…Maquet Critical Care AB · 2020
Show all 12 generations
- Root · 12 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 11 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 10 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 9 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- 8 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
- 7 generations backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
- 6 generations backK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
- 5 generations backK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
- 4 generations backK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
- 3 generations backK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
- 2 generations backK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
- 1 generation backK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017
- This deviceK191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e…Maquet Critical Care AB · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −11 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −10 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −9 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| −8 | K061609 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2006 | 1 |
| −7 | K071142 | GE Datex-Ohmeda Avance Anesthesia System | Datex-Ohmeda | 2007 | — |
| −6 | K081844 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2008 | 4 |
| −5 | K090233 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2009 | 2 |
| −4 | K102182 | Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 | Maquet Critical Care AB | 2011 | — |
| −3 | K112114 | Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 | Maquet Critical Care AB | 2012 | Class I |
| −2 | K133958 | Flow-I Anesthesia System C20, C30 & C40 | Maquet Critical Care AB | 2014 | Class I |
| −1 | K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia… | Maquet Critical Care AB | 2017 | — |
| 0 (this device) | K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Summary page 5…Regulation Number 21 CFR 868.5160 Predicate Device Identification Maquet FLOW-i Anesthesia System K160665 Reference Device Identification GE Aisys CS2 K170872… | 2017 |
| † | K170872 | Aisys CS2 | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2026 | Class II | Z-2860-2026 | Under Investigation by firm | 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 lead to intraoperative awareness. |
| Jan 15, 2025 | Class I | Z-1074-2025 | Device Design | 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 irritation of respiratory tract, which… |
| May 1, 2024 | Class I | Z-1877-2024 | Under Investigation by firm | 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 irritation of respiratory tract, which… |
| Dec 22, 2022 | Class I | Z-0959-2023 | Software Design Change | 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 hypoventilation and hypoxia. |
| Dec 22, 2022 | Class I | Z-0961-2023 | Software Design Change | 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 hypoventilation and hypoxia. |
| Dec 22, 2022 | Class I | Z-0960-2023 | Software Design Change | 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 hypoventilation and hypoxia. |
| Nov 7, 2022 | Class II | Z-0422-2023 | Component design/selection | 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 of a mains power failure. This could… |
| May 2, 2022 | Class I | Z-1279-2022 | Component design/selection | 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 unit from being activated. |
| May 2, 2022 | Class I | Z-1278-2022 | Component design/selection | 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 unit from being activated. |
| Dec 9, 2021 | Class I | Z-0468-2022 | Under Investigation by firm | 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 | Device Design | 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 Anesthesia machine. |
The 5 latest of 11 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 8 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 14 of the 38 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191027 · printed Nov 3, 2026
Cite this page
510(k) Report. “K191027: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K191027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026