510(k) Report

510(k) · Cleared

Cleared

Kion Anesthesia System

K973971510(k) TraditionalCleared Sep 13, 1999696-day reviewClass II21 CFR 868.5160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · BSZ Gas-Machine, Anesthesia

Cleared on Sep 13, 1999 as substantially equivalent to K841529 (Siemens Elema AB, 1984) and 12 other predicates after a 696-day review. Its family tree reaches back 2 generations to 1991. 3 of the 21 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.

Decided
Sep 13, 1999
Review
696 days
Class
Class II
Product code
BSZ
Recalls
None
Predicates
13

Its longest line of descent runs back 2 generations to K902859 (1991). 14 ancestors in all, the oldest K841529 (1984). 6 later devices descend from it, 1 citing it directly. 3 of the 21 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1993: 1 other ancestor1989: 2 other ancestors1987: 1 other ancestor1986: 1 other ancestor1985: 2 other ancestors1984: 2 other ancestors2004: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared, 1 with a Class I recall12017: 1 descendant cleared2020: 1 descendant cleared, 1 with a Class I recall1K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalledK960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant, 1 with a Class I recall14 generations forward: 1 descendant, 1 with a Class I recall15 generations forward: 1 descendant6 generations forward: 1 descendant, 1 with a Class I recall1 K960010 · Servo Ventilator 300 Computer Interface · Siemens Elema AB · 1996K902859 · Servo Ventilator 300 · Siemens Life Support Systems · 1991 · recalled0+5
  1. Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
  2. 1 generation backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
  3. This deviceK973971 Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999
  4. Descendant · cites it directly · 5 of its ownK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
  6. Descendant · 3 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)
  7. Descendant · 4 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
  8. Descendant · 5 generations on · 1 of its ownK160665 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i…Maquet Critical Care AB · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12011: 12012: 12014: 12017: 12020: 1
2004high 1 (2004) · low 0 (2005)2026

Class I recalls in this family

  • K112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet…3 generations on · 2012
  • K133958 Flow-I Anesthesia System C20, C30 & C404 generations on · 2014
  • K191027 Flow-i Anesthesia System, Flow-c Anesthesia…6 generations on · 2020

Most influential descendants

Showing 5 of 6 · See all
  • K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc. · 2004 · cites it directly5descendants
  • K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · 2 generations on4descendants
  • K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 3 generations on3descendants
  • K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 4 generations on2descendants
  • K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB · 2017 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K902859Servo Ventilator 300Siemens Life Support Systems19913
−1K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB1996—
0 (this device)K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc.1999—
+1K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64…Siemens Medical Solutions USA, Inc.20041
+2K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB2011—
+3K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB2012Class I
+4K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB2014Class I
+5K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia…Maquet Critical Care AB2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198420
198520
198610
198710
198920
199310
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
201211
201411
201710
202011
FIG. 1 — Lineage of K973971, 1991–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 BSZ device

  1. #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (13)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K841529Siemens-Elema Ventilator 900C
Summary page 2
…Notification Siemens KION 3. Predicate Device Identification: Legally marketed devices to which equivalence is being claimed 510(k) # Siemens Servo Ventilator 900C K841529 Servo Ventilator 900C/D Electronic gas supply unit K871354 Servo Ventilator 900C/D CAV 1.0 Master Program Flow & Prs, CO2 Lung…
Siemens Elema AB1984—
*K871354Servo Ventilator 900 C/D
Summary page 2
…n: Legally marketed devices to which equivalence is being claimed 510(k) # Siemens Servo Ventilator 900C K841529 Servo Ventilator 900C/D Electronic gas supply unit K871354 Servo Ventilator 900C/D CAV 1.0 Master Program Flow & Prs, CO2 Lung Monitor K861707 Servo Ventilator 900C/D P.C. Interface K8…
Siemens Elema AB1987—
*K861707Master Program Flow & Pressure CO2 & Lung Monitor
Summary page 2
…Servo Ventilator 900C K841529 Servo Ventilator 900C/D Electronic gas supply unit K871354 Servo Ventilator 900C/D CAV 1.0 Master Program Flow & Prs, CO2 Lung Monitor K861707 Servo Ventilator 900C/D P.C. Interface K852771 Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics K923444/A Servo Venti…
Siemens Elema AB1986—
*K852771PC Interface
Summary page 2
…900C/D Electronic gas supply unit K871354 Servo Ventilator 900C/D CAV 1.0 Master Program Flow & Prs, CO2 Lung Monitor K861707 Servo Ventilator 900C/D P.C. Interface K852771 Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics K923444/A Servo Ventilator 900C/D Man. Vent. Acc. K854036 Servo Vent…
Siemens Elema AB1985—
*K923444Servo Graphics
Summary page 2
…D CAV 1.0 Master Program Flow & Prs, CO2 Lung Monitor K861707 Servo Ventilator 900C/D P.C. Interface K852771 Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics K923444/A Servo Ventilator 900C/D Man. Vent. Acc. K854036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthes…
Siemens Medical Solutions USA, Inc.1993—
*K854036Manual Ventilation Accessory
Summary page 2
…r K861707 Servo Ventilator 900C/D P.C. Interface K852771 Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics K923444/A Servo Ventilator 900C/D Man. Vent. Acc. K854036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/9…
Siemens Elema AB1985—
*K890932Cav 3.0C Software Program
Summary page 2
…52771 Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics K923444/A Servo Ventilator 900C/D Man. Vent. Acc. K854036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens S…
Siemens Life Support Systems1989—
*K893786Servo Anesthesia Circle 985
Summary page 2
…e Servo Graphics K923444/A Servo Ventilator 900C/D Man. Vent. Acc. K854036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens Servo Ventilator 300 K960010 Siemens SC9000/S…
Siemens Life Support Systems1989—
*K841157Halothane Vaporizer 950, Enflurane
Summary page 2
…ator 900C/D Man. Vent. Acc. K854036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens Servo Ventilator 300 K960010 Siemens SC9000/SC9015 Bedside Monitoring System K946306…
Siemens Elema AB1984—
*K942091Ohmeda Tec 5 Vaporizer for Use with Sevoflurane
Summary page 2
…4036 Servo Ventilator 900C/D/E CAYV 3.0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens Servo Ventilator 300 K960010 Siemens SC9000/SC9015 Bedside Monitoring System K946306 4. Device Description: KION is…
Ohmeda Medical1995—
*K960010Servo Ventilator 300 Computer Interface
Summary page 2
…0 Software K890932 Siemens Servo Anesthesia Circle 985 K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens Servo Ventilator 300 K960010 Siemens SC9000/SC9015 Bedside Monitoring System K946306 4. Device Description: KION is a modular anesthesia system. It is ava…
Siemens Elema AB1996—
*K946306Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System
Summary page 2
…K893786 Siemens Vaporizers 950/951/952 K841157 Ohmeda Tec5 Vaporizer K942091 Siemens Servo Ventilator 300 K960010 Siemens SC9000/SC9015 Bedside Monitoring System K946306 4. Device Description: KION is a modular anesthesia system. It is available as a set of hardware and software options, which ca…
Siemens Medical Solutions USA, Inc.1995—
*K960168Siemens Servo Screen 390 and Servo Computer Module 990
Summary page 3
…tilator 300 - K960010 e Servo Anesthesia Circle 985 -K893786. e Siemens Vaporisers 950, 951, 952 - K841157. e Ohmeda Tec 5 vaporiser - K942091. e Siemens Servo Screen - K960168 Parameters General Predicate devices: All Modified Device Explanation of the differences compared Kion Anesthesia System to the P…
Siemens Elema AB1996—

Also cleared against K841529: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc.20045

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

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 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 4 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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

What does this lineage say?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K024213 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K841529.

How does its category compare?

All BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSZ

1in 2025

2007: 32008: 82009: 32010: 12011: 62012: 52013: 52014: 42015: 42016: 12017: 32018: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 8 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSZ

145in 2017

2007: 175 days median2008: 99 days median2009: 34 days median2011: 218 days median2012: 134 days median2013: 125 days median2014: 235 days median2015: 134 days median2017: 145 days median
2007high 235 (2014) · low 34 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSZ

5in 2025

2007: 12008: 82009: 32010: 142011: 12012: 7, 6 Class I2013: 5, 5 Class I2015: 7, 2 Class I2016: 12017: 5, 1 Class I2018: 32019: 5, 2 Class I2020: 72021: 2, 1 Class I2022: 4, 3 Class I2023: 62024: 13, 13 Class I2025: 5, 3 Class I2026 (partial year): 7, 2 Class I
2007high 14 (2010) · low 0 (2014)2026

Class I (38 since 2007) Class II/III not classified

Adverse event reports per year · BSZ

9,198in 2025

2007: 1322008: 1042009: 852010: 972011: 872012: 892013: 3082014: 2792015: 5722016: 2,1352017: 2,3552018: 2,5892019: 1,9572020: 2,6872021: 3,1232022: 4,3522023: 5,5952024: 6,0672025: 9,198
2007high 9,198 (2025) · low 85 (2009)2025

MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731751132
20088998104
2009334385
20101—1497
20116218187
201251347 (6)89
201351255 (5)308
201442350279
201541347 (2)572
20161—12,135
201731455 (1)2,355
20182—32,589
20190—5 (2)1,957
20201—72,687
20211—2 (1)3,123
20220—4 (3)4,352
20232—65,595
20240—13 (13)6,067
20251—5 (3)9,198
20262—7 (2)—

What is it indicated for?

Use of the KION Anesthesia System is indicated for adult or infant populations 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 the patient. This device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability to breathe.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K841529

1 other device cites the same predicate.

  • K082657RTX RespiratorMedivent Limited · 2008

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

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  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

Recent decisions in BSZ

The BSZ category page

  • K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
  • K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series…Codonics.Incorporated · 2025
  • K230931AtlanDrägerwerk AG Co. Kgaa · 20238 Class I recalls
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls

https://510kreport.com/device/K973971 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973971: Kion Anesthesia System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973971

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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