510(k) · Cleared
Recalled · Class II · 2018Aisys CS2
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 Aug 15, 2017 as substantially equivalent to K132530 (Datex-Ohmeda, Inc., 2013) after a 145-day review. Its family tree reaches back 14 generations to 1991. 7 of the 87 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times.
- Decided
- Aug 15, 2017
- Review
- 145 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 14 generations to K902859 (1991). 86 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 7 of the 87 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations between
- 3 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 2 generations backK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 1 generation backK132530 GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc. · 2013 · Recalled
- This deviceK170872 Aisys CS2Datex-Ohmeda, Inc. · 2017
Show all 14 generations
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 12 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 11 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 10 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 9 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 8 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 7 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 4 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 3 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 2 generations backK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- 1 generation backK132530 GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc. · 2013 · Recalled
- This deviceK170872 Aisys CS2Datex-Ohmeda, Inc. · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −13 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −12 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −11 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −10 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −9 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −8 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −7 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −4 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| −3 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| −2 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | Class I |
| −1 | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2) | Datex-Ohmeda, Inc. | 2013 | 3 |
| 0 (this device) | K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017 | — |
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 |
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.
7 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 |
|---|---|---|---|
| * | K132530 | GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Summary page 4…Product Code: BSZ Regulation Number: 21 CFR 868.5160 Gas Machine, Anesthesia Predicate Device(s): GE Datex-Ohmeda Aisys CS2 Anesthesia System (K132530) 1 Intended Use: The Aisys CS2 anesthesia system… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 27, 2018 | Class II | Z-0413-2019 | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous… |
| Sep 27, 2018 | Class II | Z-0411-2019 | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous… |
| Sep 27, 2018 | Class II | Z-0412-2019 | Software design | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous… |
| Oct 4, 2017 | Class II | Z-1199-2018 | Process control | Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming. |
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 · 2 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 · 4 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 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 8 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 8 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 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 30 of the 86 ancestors have a recall of any class; 7 have a Class I recall.
- 1 other device also cites its predicate K132530.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide ride 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/K170872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170872: Aisys CS2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170872
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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