510(k) · Cleared
Recalled · 2005Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Mar 23, 2004 as substantially equivalent to K973971 (Siemens Medical Solutions USA, Inc., 1999) and 6 other predicates after a 459-day review. Its family tree reaches back 3 generations to 1991. 3 of the 25 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Mar 23, 2004
- Review
- 459 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 3 generations to K902859 (1991). 19 ancestors in all, the oldest K811102 (1981). 5 later devices descend from it, 1 citing it directly. 3 of the 25 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 1 generation backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- This deviceK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
- Descendant · 2 generations on · 3 of its ownK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
- Descendant · 4 generations on · 1 of its ownK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017
- Descendant · 5 generations on · 0 of its ownK191027 Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e…Maquet Critical Care AB · 2020 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · cites it directly4descendants
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 2 generations on3descendants
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 3 generations on2descendants
- K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB · 2017 · 4 generations on1descendant
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −1 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| 0 (this device) | K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64… | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K102182 | Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 | Maquet Critical Care AB | 2011 | — |
| +2 | K112114 | Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 | Maquet Critical Care AB | 2012 | Class I |
| +3 | K133958 | Flow-I Anesthesia System C20, C30 & C40 | Maquet Critical Care AB | 2014 | Class I |
| +4 | K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia… | Maquet Critical Care AB | 2017 | — |
| +5 | K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2014 | 1 | 1 |
| 2017 | 1 | 0 |
| 2020 | 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.
3 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K973971 | Kion Anesthesia SystemSummary page 1…to which equivalence is being claimed 510(k) # KION Anesthesia Workstation K973971 Modification to KION Anesthesia Workstation K001315 KION Anesthesia Workstation… | 1999 |
| * | K001315 | Modification to Kion Anesthesia SystemSummary page 1…tion K973971 Modification to KION Anesthesia Workstation K001315 KION Anesthesia Workstation - Pressure Control Functionality K010923 Servo Ventilator 300A… | 2000 |
| * | K010923 | Kion Anaesthesia System, Model 65 03 879 E392ESummary page 1…esthesia Workstation K001315 KION Anesthesia Workstation - Pressure Control Functionality K010923 Servo Ventilator 300A K970839 Servo Ventilator 900C Sieme… | 2002 |
| * | K970839 | Servo Ventilator 300ASummary page 1…tion - Pressure Control Functionality K010923 Servo Ventilator 300A K970839 Servo Ventilator 900C Siemens-Elema AB K811102 Servo Anesthesia Circle 985… | 1997 |
| * | K811102 | Siemens-Elema AB Servo Ventilator 900 CSummary page 1…K970839 Servo Ventilator 900C Siemens-Elema AB K811102 Servo Anesthesia Circle 985 Siemens-Elema AB K893786 Other relevant submissions… | 1981 |
| * | K893786 | Servo Anesthesia Circle 985Summary page 1…iemens-Elema AB K811102 Servo Anesthesia Circle 985 Siemens-Elema AB K893786 Other relevant submissions Devices 510(k) #… | 1989 |
| * | K902859 | Servo Ventilator 300Summary page 2…orkstation with Pressure Control Functionality (KO10923) as well as to the predicate devices, the Siemens Servo Ventilator 900 C (K811102), Siemens Servo Ventilator 300 (K902859), and Servo Anesthesia Circle 985 (K893786). The technical differences are more of physical dimensions (compared to the SV900 an… | 1991 |
| † | K010925 | Servoi Ventilator System, Model 64 87 800 E407E | 2001 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102182 | Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 | 2011 | 4 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2005 | Not classified | Z-0710-05 | Other | Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality. |
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.
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K102182 (Maquet Critical Care AB, 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a…
Read the full statement (116 words)
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024213 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024213: Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910 E392E, 65 22 572 E397E, 65 03 655.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024213
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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