510(k) · Cleared
ClearedSC 6000/ SC 6000P/ R50
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 Apr 10, 1995 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 248 later devices descend from it.
- Decided
- Apr 10, 1995
- Review
- 216 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
248 later devices descend from it, 2 citing it directly.
- This deviceK944350 SC 6000/ SC 6000P/ R50Siemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 247 of its ownK955743 Siemens SC 6000/SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 246 of its ownK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
- Descendant · 2 generations on · 244 of its ownK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
Showing 5 of 248 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 248 · See all- K955743Siemens SC 6000/SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1996 · cites it directly247descendants
- K993974Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000 · cites it directly246descendants
- K033600Infinity GammaxlDraeger Medical Systems, Inc. · 2003 · 2 generations on244descendants
- K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · 2 generations on241descendants
- K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · 3 generations on230descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944350 | SC 6000/ SC 6000P/ R50 | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K955743 | Siemens SC 6000/SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +1 | K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | Siemens Medical Solutions USA, Inc. | 2000 | — |
| +2 | K033600 | Infinity Gammaxl | Draeger Medical Systems, Inc. | 2003 | — |
| +2 | K040188 | Infinity Gammaxl and SC 6802XL with the Scio Gas Module | Draeger Medical Systems, Inc. | 2004 | — |
| +3 | K051628 | Infinity Monitors with Scio Modifications | Draeger Medical Systems, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 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.
Planning a device in DSI? 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? (248)
See all 2482 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955743 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 247 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/K944350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944350: SC 6000/ SC 6000P/ R50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944350
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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