510(k) · Cleared
Recalled · Class I · 2026Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
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 Apr 20, 2021 as substantially equivalent to K180098 (Maquet Critical Care AB, 2019) after a 287-day review. Its family tree reaches back 14 generations to 1991. 6 of the 66 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 4 Class I recalls.
- Decided
- Apr 20, 2021
- Review
- 287 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5 (4 Class I)
- Predicates
- 1
Its longest line of descent runs back 14 generations to K902859 (1991). 65 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 6 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations between
- 3 generations backK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- 2 generations backK151814 SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015
- 1 generation backK180098 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System…Maquet Critical Care AB · 2019
- This deviceK201874 Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1…Maquet Critical Care AB · 2021
Show all 14 generations
- Root · 14 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 13 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 12 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 11 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 10 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 9 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 8 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 7 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 4 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 3 generations backK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- 2 generations backK151814 SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB · 2015
- 1 generation backK180098 SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System…Maquet Critical Care AB · 2019
- This deviceK201874 Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1…Maquet Critical Care AB · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −13 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −12 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −11 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −10 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −9 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −8 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −7 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −4 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| −3 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 2 |
| −2 | K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Maquet Critical Care AB | 2015 | — |
| −1 | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Maquet Critical Care AB | 2019 | — |
| 0 (this device) | K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR… | Maquet Critical Care AB | 2021 | — |
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 |
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.
6 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? (1)
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 |
|---|---|---|---|
| * | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Summary page 5…Regulation Number 21 CFR 868.5895 Predicate Device Identification Maquet Servo-u/n Ventilator System K180098 Reference Device Identification Maquet Servo-i Ventilator System K123149… | 2019 |
| † | K123149 | Servo-I Ventilator System | 2014 |
| † | K181695 | Nihon Kohden NKV-550 Series Ventilator System | 2018 |
| † | K193228 | Hamilton-G5 | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2026 | Class II | Z-2963-2026 | Under Investigation by firm | Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing. |
| May 30, 2025 | Class I | Z-2014-2025 | Under Investigation by firm | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier. |
| May 30, 2025 | Class I | Z-2015-2025 | Under Investigation by firm | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier. |
| May 30, 2025 | Class I | Z-2013-2025 | Under Investigation by firm | Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier. |
| Jul 20, 2022 | Class I | Z-1560-2022 | Software in the Use Environment | Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and… |
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 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 7 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 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 18 of the 65 ancestors have a recall of any class; 5 have a Class I recall.
- 2 other devices also cite its predicate K180098.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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-u Ventilator System is: * intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients * to be used only by healthcare providers * to be used only in professional healthcare facilities and for transport within these facilities The Servo-n Ventilator System is: * intended for respiratory support, monitoring and treatment of neonatal and pediatric patients * to be used only by healthcare providers * to be…
Read the full statement (153 words)
The Servo-u Ventilator System is:
* intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
* to be used only by healthcare providers
* to be used only in professional healthcare facilities and for transport within these facilities
The Servo-n Ventilator System is:
* intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
* to be used only by healthcare providers
* to be used only in professional healthcare facilities and for transport within these facilities
The Servo-u MR Ventilator System is:
* intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
* to be used only by healthcare providers
* to be used only in professional healthcare facilities and for transport within these facilities
* to be used in MR environment according to specified conditions
- with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201874: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201874
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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