510(k) · Cleared
Recalled · Class II · 2020Servo-I Ventilator System
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 20, 2014 as substantially equivalent to K073179 (Maquet Critical Care AB, 2008) and 1 other predicate after a 623-day review. Its family tree reaches back 11 generations to 1991. 8 of the 72 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 20, 2014
- Review
- 623 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 11 generations to K902859 (1991). 62 ancestors in all, the oldest K883038 (1988). 9 later devices descend from it, 3 citing it directly. 8 of the 72 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- This deviceK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014
- Descendant · cites it directly · 4 of its ownK151814 SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015
- Descendant · 2 generations on · 3 of its ownK180098 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System…Maquet Critical Care AB · 2019
- Descendant · cites it directly · 1 of its ownK153688 Edi Catheter ENFitMaquet Critical Care AB · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK142679 Carescape R860Datex-Ohmeda, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm…Maquet Critical Care AB · 2026
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- This deviceK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015 · cites it directly4descendants
- K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB · 2019 · 2 generations on3descendants
- K153688Edi Catheter ENFitMaquet Critical Care AB · 2017 · cites it directly1descendant
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · cites it directly1descendant
- K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −1 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| 0 (this device) | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | — |
| +1 | K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | 2015 | — |
| +2 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | 2019 | — |
| +1 | K153688 | Edi Catheter ENFit | Maquet Critical Care AB | 2017 | 1 |
| +1 | K142679 | Carescape R860 | Datex-Ohmeda, Inc. | 2015 | Class I |
| +2 | K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273)… | Maquet Critical Care AB | 2026 | — |
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 |
|---|---|---|
| 2015 | 2 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 1 |
| 2021 | 2 | 1 |
| 2025 | 1 | 0 |
| 2026 | 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.
8 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? (2)
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 |
|---|---|---|---|
| * | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Summary page 1…eted devices to which equivalence is being claimed I510(k) # IModel of Subject device SROiVentilator system K073 179 SERVO-i SERVO-i Ventilator system K04 1223 SERVO-s… | 2008 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…SROiVentilator system K073 179 SERVO-i SERVO-i Ventilator system K04 1223 SERVO-s Volume 3 of 3 - Page 167 of 204… | 2004 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 17, 2020 | Class II | Z-0092-2021 | Device Design | A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully. |
| Jan 12, 2015 | Class II | Z-1224-2015 | Device Design | A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function. |
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 · 3 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
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 14 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 62 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K151814 (Maquet Critical Care AB, 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K073179.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will…
Read the full statement (152 words)
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 added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube.
The SERVO-i Ventilator is classified as MR Conditional for I .T. I.5T and 3T MR scanner. This means that ir is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.
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/K123149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123149: Servo-I Ventilator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123149
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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