510(k) · Cleared
ClearedServo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Critical Care AB · CBK Ventilator, Continuous, Facility Use
Cleared on Jun 9, 2008 as substantially equivalent to K063404 (Maquet Critical Care AB, 2007) and 2 other predicates after a 209-day review. Its family tree reaches back 10 generations to 1991. 18 of the 90 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 209 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K902859 (1991). 61 ancestors in all, the oldest K883038 (1988). 28 later devices descend from it, 4 citing it directly. 18 of the 90 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations between
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- This deviceK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · cites it directly · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- Descendant · cites it directly · 6 of its ownK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- Descendant · 2 generations on · 5 of its ownK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK151814 SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015
Show all 10 generations
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 8 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 7 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 6 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 5 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 4 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- This deviceK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K131774Hamilton-G5Hamilton Medical AG · 2013 · cites it directly10descendants
- K123149Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · cites it directly9descendants
- K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009 · cites it directly6descendants
- K103211Avea VentilatorCare Fusion · 2011 · 2 generations on5descendants
- K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −9 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −8 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −7 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −6 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −5 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| 0 (this device) | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +1 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +1 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 2 |
| +1 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| +2 | K103211 | Avea Ventilator | Care Fusion | 2011 | Class I |
| +2 | K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | 2015 | — |
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 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 4 | 2 |
| 2019 | 3 | 1 |
| 2020 | 4 | 3 |
| 2021 | 3 | 2 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
18 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K063404 | Servo-I Ventilator System, Models 64, 87 and 800Summary page 1…Legally marketed devices to which equivalence is being claimed 510(k) # Maguet, SERVO-i Ventilator System K063404 Viasys, Avea with Heliox option K022674 GE Datex-Ohmeda, Apta6r Heliox Delivery… | 2007 |
| * | K022674 | Bird Avea VentilatorSummary page 1…# Maguet, SERVO-i Ventilator System K063404 Viasys, Avea with Heliox option K022674 GE Datex-Ohmeda, Apta6r Heliox Delivery System K041524 Device Description Summar… | 2002 |
| * | K041524 | GE Datex-Ohmeda Heliox Delivery SystemSummary page 1…4 Viasys, Avea with Heliox option K022674 GE Datex-Ohmeda, Apta6r Heliox Delivery System K041524 Device Description Summary of technological characteristics of modified Device and Predicate Device: The predicat… | 2004 |
What descends from it? (28)
See all 284 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (18 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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 18 shown.
Nearest 5 of 18; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 61 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K131774 (Hamilton Medical AG, 2013) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K063404.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The SERVO-i Ventilator System with Heliox option is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities. The SERVO-i Ventilator System with Heliox option is also MR conditional.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073179: Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073179
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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