510(k) · Cleared
ClearedSiemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jun 27, 1995 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 353 devices in its family, counting itself, have a Class I recall. 352 later devices descend from it.
- Decided
- Jun 27, 1995
- Review
- 181 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
352 later devices descend from it, 9 citing it directly. 3 of the 353 devices in this family, counting this one, have a Class I recall.
- This deviceK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 309 of its ownK980882 Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 298 of its ownK982730 SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- Descendant · 2 generations on · 293 of its ownK983632 Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 293 of its ownK970348 Siemens SC/9000/SC9015 Series Surgical Display ControllerSiemens Medical Solutions USA, Inc. · 1997
- Descendant · 2 generations on · 292 of its ownK012770 Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002
Showing 5 of 352 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 352 · See all- K980882Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998 · cites it directly309descendants
- K982730SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998 · cites it directly298descendants
- K983632Siemens SC 8000 Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998 · 2 generations on293descendants
- K970348Siemens SC/9000/SC9015 Series Surgical Display ControllerSiemens Medical Solutions USA, Inc. · 1997 · cites it directly293descendants
- K012770Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002 · 2 generations on292descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +2 | K983632 | Siemens SC 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K970348 | Siemens SC/9000/SC9015 Series Surgical Display Controller | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +2 | K012770 | Infinity MICRO2+ | Siemens Medical Solutions USA, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 9 | 0 |
| 2006 | 16 | 0 |
| 2007 | 8 | 0 |
| 2008 | 8 | 0 |
| 2009 | 6 | 0 |
| 2010 | 11 | 0 |
| 2011 | 13 | 0 |
| 2012 | 12 | 1 |
| 2013 | 16 | 0 |
| 2014 | 12 | 1 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 17 | 0 |
| 2018 | 18 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 1 |
| 2021 | 17 | 0 |
| 2022 | 22 | 0 |
| 2023 | 24 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 0 |
| 2026 | 15 | 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.
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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (352)
See all 3529 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980882 | Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | 1998 | 309 |
| K982730 | SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor | 1998 | 298 |
| K970348 | Siemens SC/9000/SC9015 Series Surgical Display Controller | 1997 | 293 |
| K955743 | Siemens SC 6000/SC 6000 P Portable Bedside Monitoring System | 1996 | 247 |
| K965062 | Siemens SC9000/SC9015 Multigas and Multigas+ Modules | 1997 | 18 |
| K973971 | Kion Anesthesia System | 1999 | 6 |
| K121999 | General Purpose Temperature Probe, Skin Temperature Probe | 2013 | 5 |
| K970920 | Siemens SC9000/SC9015 Bedside Monitoring System | 1997 | 2 |
| K964624 | Siemens SC9000/SC9015 Bedside Monitoring System | 1997 | 0 |
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, K980882 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 309 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K946306 · printed Nov 5, 2026
Cite this page
510(k) Report. “K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946306
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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