510(k) · Cleared
ClearedSiemens SC9000/SC9015 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 Sep 11, 1997 as substantially equivalent to K946306 (Siemens Medical Solutions USA, Inc., 1995) and 1 other predicate after a 303-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 11, 1997
- Review
- 303 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K946306 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
- This deviceK964624 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System | Siemens Medical Solutions USA, Inc. | 1995 | — |
| 0 (this device) | K964624 | Siemens SC9000/SC9015 Bedside Monitoring System | Siemens Medical Solutions USA, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSummary page 2…proves the detection and monitoring of arrhythmia. The Siemens SC9000/SC9015 Bedside Monitoring Systems was granted 510(K) clearance under the following 510(K) numbers: K946306 - Siemens SC9000/SC9015 Monitor (Original Submission) K954632 - Siemens SC9000/SC9015 Monitor with etCO, Functionality The follo… | 1995 |
| * | K954632 | Siemens SC 9000 ETCO2 ModuleSummary page 2…SC9000/SC9015 Bedside Monitoring Systems was granted 510(K) clearance under the following 510(K) numbers: K946306 - Siemens SC9000/SC9015 Monitor (Original Submission) K954632 - Siemens SC9000/SC9015 Monitor with etCO, Functionality The following submission is currently awaiting FDA 510(K) clearance: K9… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 8 other devices also cite its predicate K946306.
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?
This device is capable of monitaring: ¢ heartrate * respiration rawe * invasive pressure + non-invasive pressure e amrhythmia ¢ emperature * cardiac output s arterial oxygen saturation * pulserate e cardiac output end-tidal carbon dioxide and (central) apnea This device can be connected to third party devices, Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac output monitor. The device is intended to be used in the…
Read the full statement (165 words)
This device is capable of monitaring:
¢ heartrate
* respiration rawe
* invasive pressure
+ non-invasive pressure
e amrhythmia
¢ emperature
* cardiac output
s arterial oxygen saturation
* pulserate
e cardiac output
end-tidal carbon dioxide and (central) apnea
This device can be connected to third party devices, Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac output monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.¢. Pbysicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessinent of the patent’s medical condition. The device is intended to be used on Adult, Pediatric and Neonatal populations, with rhe exceprion of the parameter Cardiac Output which is intended for use in the adult and pediatric popularions only; and Arrhythmia which is intended for use in the adult population only.
MRI Compatibility Statement:
‘The Siemens SCS000/SC9015 Series is not compatible for use in an MRI magnetic field.
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/K964624 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964624: Siemens SC9000/SC9015 Bedside Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964624
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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