510(k) · Cleared
Recalled · Class II · 2025A8, A9 Anesthesia System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · BSZ Gas-Machine, Anesthesia
Cleared on Mar 26, 2021 as substantially equivalent to K171292 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2018) and 1 other predicate after a 255-day review. Its family tree reaches back 17 generations to 1991. 10 of the 122 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Mar 26, 2021
- Review
- 255 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 17 generations to K902859 (1991). 120 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 10 of the 122 devices in this family, counting this one, have a Class I recall.
- Root · 17 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations between
- 3 generations backK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 2 generations backK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- 1 generation backK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- This deviceK201957 A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK253330 A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 16 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 15 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 14 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 13 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 12 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 11 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 10 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 9 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 8 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 7 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 6 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 5 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 4 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 3 generations backK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- 2 generations backK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- 1 generation backK171292 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2018
- This deviceK201957 A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −16 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −15 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −14 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −13 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −12 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −11 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −10 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −9 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −8 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −7 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −6 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −5 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| −4 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| −3 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| −2 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
| −1 | K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018 | — |
| 0 (this device) | K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021 | — |
| +1 | K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 7 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 11 | 2 |
| 1999 | 7 | 0 |
| 2000 | 6 | 1 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 1 |
| 2004 | 13 | 1 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 2 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
10 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? (2)
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 |
|---|---|---|---|
| * | K171292 | A7 Anesthesia SystemSummary page 5…Oxygen Gas Analyzer Oxygen Gas Analyzer 880.6740, II KDP Vacuum Vacuum 3. PREDICATE DEVICES Primary predicate: • K171292 - A7 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics Co., Ltd. Secondary predicate: • K192972 - BeneVision N Ser… | 2018 |
| * | K192972 | Patient MonitorSummary page 5…Vacuum 3. PREDICATE DEVICES Primary predicate: • K171292 - A7 Anesthesia System, ShenZhen Mindray Bio-Medical Electronics Co., Ltd. Secondary predicate: • K192972 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVisi… | 2020 |
| † | K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | 2017 |
| † | K151570 | Carestation 620/650/650C | 2016 |
| † | K083050 | Evite XL | 2008 |
| † | K180295 | Hamilton-G5 | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | 2026 | 0 |
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2025 | Class II | Z-0720-2026 | Device Design | Potential for anesthesia leakage. |
| Oct 20, 2025 | Class II | Z-0721-2026 | Device Design | Potential for anesthesia leakage. |
| Jul 22, 2024 | Class II | Z-2949-2024 | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms… |
| Jul 22, 2024 | Class II | Z-2951-2024 | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms… |
| Jul 22, 2024 | Class II | Z-2950-2024 | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms… |
| Jul 22, 2024 | Class II | Z-2952-2024 | Nonconforming Material/Component | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms… |
The 5 latest of 6 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.
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 4 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K102471AS3700 Anesthsia Delivery SystemMindray DS USA, Inc. · 2011 · 5 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 9 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 10 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 11 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 39 of the 120 ancestors have a recall of any class; 10 have a Class I recall.
- Of its descendants, K253330 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171292.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 A8, A9 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation. The A8, A9 is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations. High Flow Nasal Cannula (HFNC) is indicated for…
Read the full statement (115 words)
The A8, A9 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient’s ventilation.
The A8, A9 is intended for use by licensed clinicians in the administration of general anesthesia, for patients requiring anesthesia within a health care facility, and can be used in adult, pediatric and neonate populations.
High Flow Nasal Cannula (HFNC) is indicated for delivery of nasal high flow oxygen to spontaneously breathing adult patients. It can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms. It is not intended for apneic ventilation. HFNC is indicated for use in adults only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201957: A8, A9 Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201957
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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