510(k) · Cleared
ClearedServo Ventilator 300 Computer Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Elema AB · CBK Ventilator, Continuous, Facility Use
Cleared on Oct 25, 1996 as substantially equivalent to K902859 (Siemens Life Support Systems, 1991) after a 297-day review. Its family tree reaches back 1 generation to 1991. 49 of the 180 devices in its family, counting itself, have a Class I recall. 178 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 297 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902859 (1991). 178 later devices descend from it, 3 citing it directly. 49 of the 180 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- This deviceK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- Descendant · cites it directly · 171 of its ownK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- Descendant · 2 generations on · 134 of its ownK993449 Bird V.I.P. Gold/SterlingBird Products Corp. · 1999 · Recalled
- Descendant · 2 generations on · 134 of its ownK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- Descendant · 3 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 4 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 178 · See all- K970839Servo Ventilator 300ASiemens Elema AB · 1997 · cites it directly171descendants
- K993449Bird V.I.P. Gold/SterlingBird Products Corp. · 1999 · 2 generations on134descendants
- K992788Bear Cub 750 PSVBear Medical Systems, Inc. · 1999 · 2 generations on134descendants
- K013642AVEABird Products Corp. · 2002 · 3 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 4 generations on114descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| 0 (this device) | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| +1 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| +2 | K993449 | Bird V.I.P. Gold/Sterling | Bird Products Corp. | 1999 | 2 |
| +2 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| +3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 3 | 1 |
| 2004 | 7 | 1 |
| 2005 | 4 | 0 |
| 2006 | 8 | 1 |
| 2007 | 5 | 1 |
| 2008 | 12 | 2 |
| 2009 | 6 | 1 |
| 2010 | 8 | 2 |
| 2011 | 15 | 7 |
| 2012 | 16 | 6 |
| 2013 | 10 | 4 |
| 2014 | 7 | 2 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 12 | 5 |
| 2018 | 3 | 1 |
| 2019 | 8 | 3 |
| 2020 | 5 | 4 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 5 | 1 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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.
49 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 |
|---|---|---|---|
| * | K902859 | Servo Ventilator 300Summary page 2…ersion 2 is a modification of the Servo Ventilator 300 and Computer Interface Version 1 which was found Substantially Equivalent on June 26, 1991 (Premarket Notification K902859). These modifications are being made to update the hardware design and to make additional software features available, while reta… | 1991 |
What descends from it? (178)
See all 1783 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (49 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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 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
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 3 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 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
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
Nearest 12 of 49 shown.
Nearest 5 of 49; all are on the web page.
What does this lineage say?
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 Siemens Servo Ventilator 300 is intended for general and critical ventilatory care for use with neonatal, infant, pediatric, and adult patients The unit is designed to be used at the bedside and for in-hospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market.
The intended use of the Computer Interface Board Version 2 is the same as for the Computer Interface Board Version 1. The CI board stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960010: Servo Ventilator 300 Computer Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960010
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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