510(k) · Cleared
Recalled · Class I · 2013Modification to Servo-I Ventilator System, Model 64 87 800 E407E
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 Jul 29, 2004 as substantially equivalent to K040221 (Maquet Critical Care AB, 2004) and 1 other predicate after an 80-day review. Its family tree reaches back 4 generations to 1991. 29 of the 88 devices in its family, counting itself, have a Class I recall. 73 later devices descend from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Jul 29, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 8 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902859 (1991). 14 ancestors in all. 73 later devices descend from it, 10 citing it directly. 29 of the 88 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 2 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 1 generation backK040221 Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled
- This deviceK041223 Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004
- Descendant · cites it directly · 61 of its ownK063404 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 · 2 generations on · 28 of its ownK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · cites it directly · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · cites it directly · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 73 · See all- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · cites it directly61descendants
- 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 · 2 generations on28descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · cites it directly26descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · cites it directly21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −2 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −1 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 1 |
| 0 (this device) | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | — |
| +1 | 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 | — |
| +2 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +1 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +1 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 1 |
| 2009 | 4 | 1 |
| 2010 | 2 | 0 |
| 2011 | 7 | 6 |
| 2012 | 6 | 2 |
| 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.
29 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 |
|---|---|---|---|
| * | K040221 | Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…Identification Legally marketed devices to which equivalence is being claimed 510(k) Servo-i Ventilatory System K040221 Evita 4, NIV option K010093 r… | 2004 |
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474Summary page 1…510(k) Servo-i Ventilatory System K040221 Evita 4, NIV option K010093 r ~~~~~~~Docu.mn… | 2001 |
What descends from it? (73)
See all 7310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | 2007 | 61 |
| K081842 | Engstrom Carestation, Engstrom Pro | 2008 | 37 |
| K070513 | Hamilton-G5 | 2007 | 26 |
| K093886 | Engstrom Carestation, Engstrom Pro | 2010 | 21 |
| K080181 | Modification to Galileo Gold | 2008 | 21 |
| K081521 | Modification to Hamilton-G5 Class I | 2008 | 16 |
| K102775 | Hamilton-C2 | 2011 | 14 |
| K123149 | Servo-I Ventilator System | 2014 | 9 |
| K061094 | Newport E500 Wave Ventilator | 2006 | 2 |
| K072926 | Helontix Vent | 2008 | 0 |
Has anything in its family been recalled? (29 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2013 | Class I | Z-1177-2013 | Device Design | When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected. |
| Dec 22, 2011 | Not classified | Z-1362-2012 | Device Design | The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing. |
| Dec 22, 2011 | Not classified | Z-1363-2012 | Device Design | The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing. |
| Sep 19, 2011 | Not classified | Z-0354-2012 | Vendor change control | Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE… |
| Sep 19, 2011 | Not classified | Z-0353-2012 | Vendor change control | Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE… |
| Sep 19, 2011 | Not classified | Z-0352-2012 | Vendor change control | Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE… |
| Jul 8, 2008 | Not classified | Z-2442-2008 | Employee error | Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators. |
| Jul 8, 2008 | Not classified | Z-2443-2008 | Employee error | Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators. |
The 5 latest of 8 recalls; the web page lists all.
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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · Cites it directly · ◆ in the 2008 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
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- 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
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
Nearest 12 of 28 shown.
Nearest 5 of 28; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 7 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K063404 (Maquet Critical Care AB, 2007) has gone furthest, with 61 descendants of its own.
- 1 other device also cites its predicate K040221.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041223
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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