510(k) · Cleared
ClearedSiemens SC 6000 & SC 6000 P Portable Bedside Monitoring 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 Jan 17, 1997 as substantially equivalent to K952054 (Siemens Medical Solutions USA, Inc., 1996) after a 210-day review. Its family tree reaches back 2 generations to 1985. 247 later devices descend from it.
- Decided
- Jan 17, 1997
- Review
- 210 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844187 (1985). 247 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
- 1 generation backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
- This deviceK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
- 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
- Descendant · 4 generations on · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 247 · See all- 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
- K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · 4 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844187 | Siemens Sirecust 404N Neonatal Monitor | Siemens Medical Solutions USA, Inc. | 1985 | — |
| −1 | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960) | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K962404 | Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +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 | — |
| +4 | K053204 | Intellivue Gas Modules, Models G5 M1019A and G1 M1013A | Draeger Medical AG & Co. Kgaa | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K952054 | Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Summary page 1…l, Invasive : Arrhythmia detector 74DST ITI 21 CFR 870.1025 & Alarm 4 Predi Device I ification: Siemens SIRECUST 1261 granted premarket approval under 510 K file number K952054. 510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement (5) Device Description: The SC 6000 and SC 6000P P… | 1996 |
What descends from it? (247)
See all 2471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993974 | Siemens Infinity SC 6002XL Portable Patient Monitor | 2000 | 246 |
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993974 (Siemens Medical Solutions USA, Inc., 2000) has gone furthest, with 246 descendants of its own.
- 1 other device also cites its predicate K952054.
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 | — |
What is it indicated for?
The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and espgsal apnea. “The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.
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/K962404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962404: Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962404
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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