510(k) · Cleared
Recalled · 2009Servo Ventilator 300A
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 14, 1997 as substantially equivalent to K960010 (Siemens Elema AB, 1996) after a 221-day review. Its family tree reaches back 2 generations to 1991. 49 of the 174 devices in its family, counting itself, have a Class I recall. 171 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 14, 1997
- Review
- 221 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902859 (1991). 171 later devices descend from it, 8 citing it directly. 49 of the 174 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- This deviceK970839 Servo Ventilator 300ASiemens Elema AB · 1997
- Descendant · cites it directly · 134 of its ownK993449 Bird V.I.P. Gold/SterlingBird Products Corp. · 1999 · Recalled
- Descendant · cites it directly · 134 of its ownK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- Descendant · 2 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 4 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 171 · See all- K993449Bird V.I.P. Gold/SterlingBird Products Corp. · 1999 · cites it directly134descendants
- K992788Bear Cub 750 PSVBear Medical Systems, Inc. · 1999 · cites it directly134descendants
- K013642AVEABird Products Corp. · 2002 · 2 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 4 generations on112descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −1 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| 0 (this device) | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | — |
| +1 | K993449 | Bird V.I.P. Gold/Sterling | Bird Products Corp. | 1999 | 2 |
| +1 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| +2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 2 | 1 |
| 2004 | 6 | 1 |
| 2005 | 3 | 0 |
| 2006 | 8 | 1 |
| 2007 | 5 | 1 |
| 2008 | 11 | 2 |
| 2009 | 6 | 1 |
| 2010 | 8 | 2 |
| 2011 | 15 | 7 |
| 2012 | 15 | 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 |
|---|---|---|---|
| * | K960010 | Servo Ventilator 300 Computer InterfaceSummary page 1…ication Name: Ventilator, Continuous (Respirator) Predicate Device The legally marketed device to which equivalence is being claimed is: Siemens Servo Ventilator 300 (K960010) Siemens-Elema AB, Electromedical Systems Division. 11(32) 510(k) Servo Ventilator 300A 12 (32) Device Descrip… | 1996 |
What descends from it? (171)
See all 1718 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993449 | Bird V.I.P. Gold/Sterling | 1999 | 134 |
| K992788 | Bear Cub 750 PSV | 1999 | 134 |
| K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | 2004 | 75 |
| K040574 | Galileo Gold | 2004 | 53 |
| K051263 | Evitaxl with Option Smartcare | 2005 | 51 |
| K060705 | Carina Home | 2006 | 22 |
| K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910… | 2004 | 5 |
| K051262 | Esprit Ventilator Neonatal Option, Model V1000 | 2005 | 0 |
Has anything in its family been recalled? (49 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. |
| Dec 19, 2008 | Not classified | Z-0872-2009 | Device Design | SERVO Ventilator 300A could cause hypoventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time. |
| 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.
- 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 · 2 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 · 2 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 · 2 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 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 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 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 · 4 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K993449 (Bird Products Corp., 1999) has gone furthest, with 134 descendants of its own.
- 2 other devices also cite its predicate K960010.
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?
Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal
patient populations in an environment where patient care is provided by
Healthcare Professionals (Physician, Nurse, Technician), when the professional
determines that a device is required to assist the breathing of the patient. The
device can be used both for controlling the entire ventilation for patients
without any ability to breathe, as well as for supporting patients with reduced
ability.
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/K970839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970839: Servo Ventilator 300A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970839
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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