510(k) · Cleared
Recalled · Class I · 2025Carestation 750/750c
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Mar 28, 2023 as substantially equivalent to K151570 (Datex-Ohmeda, Inc., 2016) after a 473-day review. Its family tree reaches back 16 generations to 1991. 10 of the 88 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Mar 28, 2023
- Review
- 473 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 16 generations to K902859 (1991). 87 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 10 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 16 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 12 generations between
- 3 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 2 generations backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- 1 generation backK151570 Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · Recalled (Class I)
- This deviceK213867 Carestation 750/750cDatex-Ohmeda, Inc. · 2023
Show all 16 generations
- Root · 16 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 15 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 14 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 13 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 12 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 11 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 10 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 9 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 8 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 7 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 6 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 5 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 4 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 3 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 2 generations backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- 1 generation backK151570 Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · Recalled (Class I)
- This deviceK213867 Carestation 750/750cDatex-Ohmeda, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −15 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −14 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −13 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −12 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −11 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −10 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −9 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −8 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −7 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −6 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −5 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −4 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| −3 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| −2 | K131945 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda | 2013 | 2 |
| −1 | K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016 | Class I |
| 0 (this device) | K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 2 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 1 |
| 2004 | 8 | 1 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K151570 | Carestation 620/650/650CSummary page 4…r Usual Name: Gas Machine, Anesthesia (21 CFR 868.5160) Regulatory Class: II Product Code: BSZ III. PREDICATE DEVICE Primary Predicate: Carestation 620/650/650c, K151570 Reference Device: Avance CS2, K131945 IV. DEVICE DESCRIPTION The GE Carestation 750/750c anesthesia machines (Carestatio… | 2016 |
| † | K131945 | GE Datex-Ohmeda Avance CS2 | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2025 | Class I | Z-0914-2026 | Component change control | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only… |
| Nov 14, 2025 | Class I | Z-0915-2026 | Component change control | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure. Anesthesia systems only… |
| Mar 21, 2025 | Class I | Z-1637-2025 | Device Design | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be… |
| Mar 21, 2025 | Class I | Z-1635-2025 | Device Design | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be… |
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.
- K151570Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 19 Class I recalls
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 4 generations back · ◆ on the line of descent in 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 · 8 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 9; all are on the web page.
What does this lineage say?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 31 of the 87 ancestors have a recall of any class; 9 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. 2023, 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 Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213867: Carestation 750/750c.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213867
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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