510(k) · Cleared
ClearedServo-I Ventilator System, Models 64, 87 and 800
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 Feb 15, 2007 as substantially equivalent to K041223 (Maquet Critical Care AB, 2004) and 4 other predicates after a 98-day review. Its family tree reaches back 9 generations to 1991. 30 of the 119 devices in its family, counting itself, have a Class I recall. 61 later devices descend from it.
- Decided
- Feb 15, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K902859 (1991). 57 ancestors in all, the oldest K883038 (1988). 61 later devices descend from it, 4 citing it directly. 30 of the 119 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · cites it directly · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · cites it directly · 28 of its ownK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · cites it directly · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · 2 generations on · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 13 of its ownK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- This deviceK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 61 · See all- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · cites it directly37descendants
- K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 2008 · cites it directly28descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · cites it directly21descendants
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on14descendants
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| +1 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +1 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +1 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +2 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
| +2 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
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 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 2 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 3 | 1 |
| 2010 | 1 | 0 |
| 2011 | 6 | 6 |
| 2012 | 3 | 1 |
| 2013 | 6 | 3 |
| 2014 | 3 | 1 |
| 2015 | 6 | 1 |
| 2016 | 2 | 2 |
| 2017 | 6 | 3 |
| 2018 | 1 | 0 |
| 2019 | 4 | 1 |
| 2020 | 4 | 3 |
| 2021 | 5 | 2 |
| 2023 | 1 | 1 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
30 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? (5)
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 |
|---|---|---|---|
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…y marketed devices to which equivalence is being claimed 510(k) # SERVO-i Ventilatory System K041223 Aestiva/5 MR] GE, Datex-Ohineda Inc. K050055 IC-2A B ic-med Devices Inc.… | 2004 |
| * | K050055 | GE Datex-Ohmeda Aestiva/5 Mri Anesthesia SystemSummary page 1…-i Ventilatory System K041223 Aestiva/5 MR] GE, Datex-Ohineda Inc. K050055 IC-2A B ic-med Devices Inc. K896380 MVP-lIO Bio-rned Devices Inc.… | 2005 |
| * | K896380 | IC-2A Mri Adult/Pediatric VentilatorSummary page 1…va/5 MR] GE, Datex-Ohineda Inc. K050055 IC-2A B ic-med Devices Inc. K896380 MVP-lIO Bio-rned Devices Inc. K896391 Vent 201 VersaMed Medical Systems I… | 1990 |
| * | K896381 | MVP-10 Mri Infant Ventilator Our reading of the summary gave K896391, FDA’s number for Bard/Angiomed Stents (C.R. Bard, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MVP-110”. | 1990 |
| * | K061627 | Modification to I Vent 201Summary page 1…IO Bio-rned Devices Inc. K896391 Vent 201 VersaMed Medical Systems Inc. K06 1627 M AQUET Ohb ubit Document TypeScio-Pg… | 2006 |
What descends from it? (61)
See all 614 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (30 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 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 30 shown.
Nearest 5 of 30; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 16 of the 57 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K081842 (Datex-Ohmeda, Inc., 2008) has gone furthest, with 37 descendants of its own.
- 9 other devices also cite its predicate K041223.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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 and for in-hospital transport
The SERVO-i Ventilator is classified as MR Conditional for 1.T, 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063404: Servo-I Ventilator System, Models 64, 87 and 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063404
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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