510(k) · Cleared
ClearedServo Ventilator System, Model 64 87 800 E407E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Sep 19, 2002 as substantially equivalent to K010925 (Siemens Elema AB, 2001) and 6 other predicates after an 80-day review. Its family tree reaches back 2 generations to 1997. 33 of the 111 devices in its family, counting itself, have a Class I recall. 102 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 80 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K962517 (1997). 8 ancestors in all. 102 later devices descend from it, 6 citing it directly. 33 of the 111 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 1 generation backK984407 Bipap Harmony S/T, Model 1001445Respironics, Inc. · 1999
- This deviceK022132 Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 75 of its ownK040221 Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled
- Descendant · 2 generations on · 73 of its ownK041223 Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · cites it directly · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
- Descendant · 2 generations on · 51 of its ownK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 102 · See all- K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · cites it directly75descendants
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations on73descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 3 generations on61descendants
- K040574Galileo GoldHamilton Medical, Inc. · 2004 · cites it directly53descendants
- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −1 | K984407 | Bipap Harmony S/T, Model 1001445 | Respironics, Inc. | 1999 | — |
| 0 (this device) | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 1 |
| +2 | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | Class I |
| +3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| +1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| +2 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 6 | 2 |
| 2005 | 2 | 0 |
| 2006 | 4 | 1 |
| 2007 | 4 | 0 |
| 2008 | 9 | 2 |
| 2009 | 4 | 1 |
| 2010 | 5 | 1 |
| 2011 | 9 | 6 |
| 2012 | 7 | 2 |
| 2013 | 6 | 3 |
| 2014 | 3 | 1 |
| 2015 | 6 | 1 |
| 2016 | 2 | 2 |
| 2017 | 6 | 3 |
| 2018 | 1 | 0 |
| 2019 | 5 | 1 |
| 2020 | 4 | 3 |
| 2021 | 6 | 2 |
| 2023 | 4 | 1 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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.
33 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? (7)
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 |
|---|---|---|---|
| * | K010925 | Servoi Ventilator System, Model 64 87 800 E407ESummary page 2…EVU-111 163 - 00 Device Description (for detailed description see Section F) The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family. The Bi-Vent mode is a Pressure controlled mode… | 2001 |
| * | K001646 | Puritan-Bennett 840 Ventilator System with Neomode Option | 2000 |
| * | K980642 | EVITA 4 (8411900)Summary page 1…I KO01646 I Evita 4 Drager K980642 Galileo Hamilton KO01686… | 1998 |
| * | K003068 | SavinaSummary page 3…tially equivalent to Puritan Bennet 840 ventilator with NeoMode option (KO01646), Drager Evita 4 - (K980642) for adult and with Neo flow for neonates , Savina (Driiger - K003068), Galileo (Hamilton - KO01686), and Harmony S/T Respironics - K984407 and Knightstar 330 (Nellcor - K003075) The technology us… | 2001 |
| * | K001686 | Galileo Ventilator | 2000 |
| * | K984407 | Bipap Harmony S/T, Model 1001445Summary page 1…ton KO01686 Harmony S/T Respironics K984407 Knightstar 330 Ne11cor KO03075 C 0 2 Anal… | 1999 |
| * | K003075 | Knightstar 330 VentilatorSummary page 3…for adult and with Neo flow for neonates , Savina (Driiger - K003068), Galileo (Hamilton - KO01686), and Harmony S/T Respironics - K984407 and Knightstar 330 (Nellcor - K003075) The technology used is assessed, verification and design validation on animals show that the Servo2 Ventilator System has the… | 2001 |
| † | K003550 | Infinity ETCO2 + Respiratory Mechanics Pod | 2001 |
What descends from it? (102)
See all 1026 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | 2004 | 75 |
| K040574 | Galileo Gold | 2004 | 53 |
| K030341 | Modification to Inspiration Ventilator System | 2004 | 4 |
| K073069 | Modification to Avea Ventilator Class I | 2008 | 3 |
| K093094 | Vela Ventilator | 2010 | 2 |
| K034040 | Esprit Ventilator, Model V1000 Class I | 2004 | 1 |
Has anything in its family been recalled? (33 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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 33 shown.
Nearest 5 of 33; all are on the web page.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K040221 (Maquet Critical Care AB, 2004) has gone furthest, with 75 descendants of its own.
- 3 other devices also cite its predicate K010925.
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' Ventilator System is intended for treatn ?nt and monitoring ofpatients in th range of neonates, infants and adults with respiratory failure or respiratory insuficiency. Servo' 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/K022132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022132: Servo Ventilator System, Model 64 87 800 E407E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022132
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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