510(k) · Cleared
Recalled · Class II · 2016GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)
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 Dec 20, 2013 as substantially equivalent to K110213 (Datex-Ohmeda, Inc., 2011) after a 130-day review. Its family tree reaches back 13 generations to 1991. 8 of the 88 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 20, 2013
- Review
- 130 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 13 generations to K902859 (1991). 85 ancestors in all, the oldest K883038 (1988). 2 later devices descend from it, 2 citing it directly. 8 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations between
- 3 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 2 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 1 generation backK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- This deviceK132530 GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK172045 Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact…Datex-Ohmeda, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK170872 Aisys CS2Datex-Ohmeda, Inc. · 2017 · Recalled
Show all 13 generations
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 12 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 11 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 10 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 9 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 8 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 7 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 6 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 3 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 2 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 1 generation backK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- This deviceK132530 GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −12 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −11 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −10 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −9 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −8 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −7 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −6 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −3 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −2 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −1 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | Class I |
| 0 (this device) | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2) | Datex-Ohmeda, Inc. | 2013 | — |
| +1 | K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100… | Datex-Ohmeda, Inc. | 2017 | Class I |
| +1 | K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017 | 4 |
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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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.
8 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 |
|---|---|---|---|
| * | K110213 | GE Datex-Ohmeda AisysSummary page 1…(a)(3) The GE Datex-Ohmeda Aisys CS2 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmedla Aisys (K1 10213). 24… | 2011 |
| † | K001814 | Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and Accessories | 2000 |
| † | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov… | 2005 |
| † | K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories | 2013 |
| † | K973985 | AS/3 Anaesthesia Delivery Unit (as/3 Adu) | 1998 |
| † | K973895 | Aladin cassette | |
| † | K092027 | Carescape Monitor B850 | 2009 |
| † | K102239 | Carescape Monitor B650 | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2016 | Class II | Z-1562-2016 | Employee error | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the… |
| Feb 17, 2016 | Class II | Z-1381-2016 | Nonconforming Material/Component | GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices. |
| Dec 15, 2015 | Class II | Z-0681-2016 | Nonconforming Material/Component | The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical ventilation cycle. If this issue is left unresolved, it could result in excessive… |
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.
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Direct predicate · ◆ 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 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 7 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 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 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 29 of the 85 ancestors have a recall of any class; 7 have a Class I recall.
- Of its descendants, K172045 (Datex-Ohmeda, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110213.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 GE Datex-Ohmeda Aisys CS 2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132530: GE Datex-Ohmeda Aisys CS2 (Aisys CS^2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132530
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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