510(k) · Cleared
Recalled · 2009Servo Ventilator 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Life Support Systems · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 26, 1991 after a 301-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 63 of the 236 devices in its family, counting itself, have a Class I recall. 235 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 26, 1991
- Review
- 301 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 3
- Predicates
- 0
235 later devices descend from it, 10 citing it directly. 63 of the 236 devices in this family, counting this one, have a Class I recall.
- This deviceK902859 Servo Ventilator 300Siemens Life Support Systems · 1991
- Descendant · cites it directly · 211 of its ownK961687 EVITA 4Drager, Inc. · 1996
- Descendant · cites it directly · 178 of its ownK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- Descendant · cites it directly · 174 of its ownK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 171 of its ownK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- Descendant · cites it directly · 151 of its ownK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
Showing 5 of 235 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 235 · See all- K961687EVITA 4Drager, Inc. · 1996 · cites it directly211descendants
- K960010Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996 · cites it directly178descendants
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · cites it directly174descendants
- K970839Servo Ventilator 300ASiemens Elema AB · 1997 · 2 generations on171descendants
- K974176Babylog 8000 PlusDrager, Inc. · 1998 · cites it directly151descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | — |
| +1 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| +1 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| +1 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| +2 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| +1 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 2 |
| 1999 | 5 | 1 |
| 2000 | 1 | 0 |
| 2002 | 6 | 3 |
| 2003 | 1 | 0 |
| 2004 | 16 | 3 |
| 2005 | 8 | 0 |
| 2006 | 11 | 1 |
| 2007 | 7 | 2 |
| 2008 | 15 | 3 |
| 2009 | 8 | 2 |
| 2010 | 12 | 3 |
| 2011 | 16 | 7 |
| 2012 | 19 | 6 |
| 2013 | 11 | 5 |
| 2014 | 9 | 3 |
| 2015 | 9 | 1 |
| 2016 | 10 | 3 |
| 2017 | 12 | 5 |
| 2018 | 3 | 1 |
| 2019 | 9 | 3 |
| 2020 | 5 | 4 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 8 | 2 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
63 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (235)
See all 23510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961687 | EVITA 4 | 1996 | 211 |
| K960010 | Servo Ventilator 300 Computer Interface | 1996 | 178 |
| K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) Class I | 1998 | 174 |
| K974176 | Babylog 8000 Plus | 1998 | 151 |
| K970165 | Evita 2 Dura | 1997 | 140 |
| K013642 | AVEA Class I | 2002 | 133 |
| K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option Class I | 1998 | 55 |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option | 2002 | 52 |
| K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910… | 2004 | 5 |
| K990897 | Nellcor Puritan Bennett 700 Series Ventilator System, and Easyneb Nebulizer | 2000 | 2 |
Has anything in its family been recalled? (63 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2009 | Not classified | Z-0588-2010 | Device Design | Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure… |
| Mar 23, 2009 | Not classified | Z-1252-2009 | Device Design | The expiratory valve in the SV 300 ventilator may stay in the open position if the printed circuit board fails. |
| Jan 3, 2005 | Not classified | Z-0571-05 | Other | Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions. |
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.
- K013642AVEABird Products Corp. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840Puritan Bennett Corp. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K103211Avea VentilatorCare Fusion · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K020357800 Series Easyneb NebulizerNellcor Puritan Bennett, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 63 shown.
Nearest 5 of 63; all are on the web page.
What does this lineage say?
- Of its descendants, K961687 (Drager, Inc., 1996) has gone furthest, with 211 descendants of its own.
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) | — |
https://510kreport.com/device/K902859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902859: Servo Ventilator 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902859
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026