510(k) · Cleared
Recalled · Class I · 2025Carestation 620/650/650C
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 Jan 21, 2016 as substantially equivalent to K131945 (Datex-Ohmeda, 2013) after a 225-day review. Its family tree reaches back 15 generations to 1991. 10 of the 88 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 14 times, including 9 Class I recalls.
- Decided
- Jan 21, 2016
- Review
- 225 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 14 (9 Class I)
- Predicates
- 1
Its longest line of descent runs back 15 generations to K902859 (1991). 86 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 10 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 1 generation backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- This deviceK151570 Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK213867 Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · Recalled (Class I)
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 13 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 12 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 11 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 10 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 9 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 8 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 7 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 5 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 4 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 3 generations backK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 2 generations backK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- 1 generation backK131945 GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 2013 · Recalled
- This deviceK151570 Carestation 620/650/650CDatex-Ohmeda, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −13 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −12 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −11 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −10 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −9 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −8 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −7 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −5 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −4 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −3 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| −2 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| −1 | K131945 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda | 2013 | 2 |
| 0 (this device) | K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016 | — |
| +1 | K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 1 |
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 |
|---|---|---|---|
| * | K131945 | GE Datex-Ohmeda Avance CS2Summary page 4…EQUIVALENCE IS MADE as required by 807.92(a)(3) The Carestation 620/650/650c is substantially equivalent to the legally marketed (predicate) Avance CS2 (K131945). DEVICE DESCRIPTION as required by 807.92(a)(4) The GE Carestation 620/650/650c anesthesia machines (Cares… | 2013 |
| † | K000706 | Datex-Ohmeda Aestiva/5 with 7100 Ventilator | 2000 |
| † | K122445 | Aespire 7900, Aespire View | 2012 |
| † | K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories | 2013 |
| † | K133576 | Monitor B40 | 2014 |
| † | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | 2003 |
| † | K102239 | Carescape Monitor B650 | 2010 |
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 |
|---|---|---|---|
| K213867 | Carestation 750/750c Class I | 2023 | 0 |
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-0913-2026 | 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-1627-2025 | 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-1632-2025 | 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-1624-2025 | 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-1628-2025 | 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-1631-2025 | 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-1634-2025 | 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… |
| Nov 25, 2019 | Class I | Z-0813-2020 | Process control | GE Healthcare has become aware that there is a potential for a loose cable connection inside specific manufactured anesthesia devices. This would cause a loss of mechanical ventilation and the system will provide high priority audio and… |
| Jul 24, 2018 | Class II | Z-2955-2018 | Nonconforming Material/Component | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air… |
| Jul 24, 2018 | Class II | Z-2954-2018 | Nonconforming Material/Component | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air… |
| Jul 24, 2018 | Class II | Z-2956-2018 | Nonconforming Material/Component | On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air… |
| Oct 11, 2017 | Class II | Z-0579-2018 | Other | Possible incomplete seal between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. |
| May 2, 2017 | Class II | Z-2703-2017 | Device Design | Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction |
The 5 latest of 14 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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 3 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 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 8 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 9 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 9 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 · 10 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K213867Carestation 750/750cDatex-Ohmeda, Inc. · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 30 of the 86 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K213867 (Datex-Ohmeda, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131945.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Carestation 620/650/650c anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (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/K151570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151570: Carestation 620/650/650C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151570
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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