510(k) · Cleared
ClearedSiemens Servo Screen 390 and Servo Computer Module 990
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 after a 283-day review. The FDA summary names its predicate without a number. 3 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 25, 1996
- Review
- 283 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly. 3 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK960168 Siemens Servo Screen 390 and Servo Computer Module 990Siemens Elema AB · 1996
- Descendant · cites it directly · 6 of its ownK973971 Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999
- Descendant · 2 generations on · 5 of its ownK024213 Siemens Kion Anesthesia Workstation - Extended Modes Functionality…Siemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 4 of its ownK102182 Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011
- Descendant · 4 generations on · 3 of its ownK112114 Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · Recalled (Class I)
- Descendant · 5 generations on · 2 of its ownK133958 Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · Recalled (Class I)
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K973971Kion Anesthesia SystemSiemens Medical Solutions USA, Inc. · 1999 · cites it directly6descendants
- K024213Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64 62 910…Siemens Medical Solutions USA, Inc. · 2004 · 2 generations on5descendants
- K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB · 2011 · 3 generations on4descendants
- K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB · 2012 · 4 generations on3descendants
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960168 | Siemens Servo Screen 390 and Servo Computer Module 990 | Siemens Elema AB | 1996 | — |
| +1 | K973971 | Kion Anesthesia System | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +2 | K024213 | Siemens Kion Anesthesia Workstation - Extended Modes Functionality, Models: 64… | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| +3 | K102182 | Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30 | Maquet Critical Care AB | 2011 | — |
| +4 | K112114 | Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40 | Maquet Critical Care AB | 2012 | Class I |
| +5 | K133958 | Flow-I Anesthesia System C20, C30 & C40 | Maquet Critical Care AB | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 1 |
| 2014 | 1 | 1 |
| 2017 | 1 | 0 |
| 2020 | 1 | 1 |
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.
3 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? (3)
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 |
|---|---|---|---|
| * | — | LEONARDO Patient Data Manager Named without a submission number | |
| * | — | 7202 Display Option Module Named without a submission number | |
| * | — | EVITA Ventilator Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973971 | Kion Anesthesia System | 1999 | 6 |
Has anything in its family been recalled? (3 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.
- 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
- K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- Of its descendants, K973971 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 6 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) | — |
What is it indicated for?
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the…
Read the full statement (133 words)
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the clinician to verify critical settings and measurements on the ventilator control panel and to obtain appropriate additional data from other sources before initiating changes in therapy.
The Servo Screen 390 does not control the ventilator, nor does it recommend specific changes in therapy or provide a diagnosis. It is a device for the formatting and display of data.
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/K960168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960168: Siemens Servo Screen 390 and Servo Computer Module 990.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960168
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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