510(k) · Cleared
ClearedSiemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis
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 Jul 8, 1998 as substantially equivalent to K915225 (Siemens Burdick, Inc., 1992) after a 204-day review. Its family tree reaches back 1 generation to 1992. 8 later devices descend from it.
- Decided
- Jul 8, 1998
- Review
- 204 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915225 (1992). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK915225 MegacartSiemens Burdick, Inc. · 1992
- This deviceK974698 Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK030738 Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 2 generations on · 5 of its ownK060307 12 RL AlgorithmGe Medical Systems Information Technologies · 2006
- Descendant · 2 generations on · 4 of its ownK101521 ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010
- Descendant · 3 generations on · 1 of its ownK150352 V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK153448 Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly7descendants
- K06030712 RL AlgorithmGe Medical Systems Information Technologies · 2006 · 2 generations on5descendants
- K101521ST/AR ST and Arrhythmia Software Model: Release K.OPhilips Medical Systems · 2010 · 2 generations on4descendants
- K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on1descendant
- K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915225 | Megacart | Siemens Burdick, Inc. | 1992 | — |
| 0 (this device) | K974698 | Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K030738 | Siemens Multiview Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +2 | K060307 | 12 RL Algorithm | Ge Medical Systems Information Technologies | 2006 | — |
| +2 | K101521 | ST/AR ST and Arrhythmia Software Model: Release K.O | Philips Medical Systems | 2010 | — |
| +3 | K150352 | V Series Monitoring System (including V12 and V21 Monitors) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K153448 | Passport Series Patient Monitors (Including Passport 8, Passport 12) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K915225 | MegacartSummary page 2…emens SC9000/SC9015 Enhanced with 12-Lead ST Segment 4. Predicate Device ldentification: Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225) 5. Device Description: The Siemens SC9000/SC9015 Bedside Monitoring, System Enhanced with 12-Lead ST Segment Analysis is an up… | 1992 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030738 | Siemens Multiview Infinity Telemetry System | 2003 | 7 |
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?
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 monitoring . Heart rate = Resprration rale . Invasive pressure . Non-invasive pressure . Arrhythmia Temperature . Cardiac output . Arterial oxygen saturation Pulse rate . End-tidal carbon dioxide (central) apnea ST segment analysis With the MultiGas™ and MultiGas+™ modules the SC3000/SC9015 is capable of measuring: . Respiration rate . Inspired and expired Carbon Dioxide (CO2) . Inspired and expired Oxygen (MultiGas+™ only) .…
Read the full statement (250 words)
This device is capable of monitoring
. Heart rate
= Resprration rale
. Invasive pressure
. Non-invasive pressure
. Arrhythmia
Temperature
. Cardiac output
. Arterial oxygen saturation
Pulse rate
. End-tidal carbon dioxide
(central) apnea
ST segment analysis
With the MultiGas™ and MultiGas+™ modules the SC3000/SC9015 is capable of measuring:
. Respiration rate
. Inspired and expired Carbon Dioxide (CO2)
. Inspired and expired Oxygen (MultiGas+™ only)
. Average inspired Oxygen (MultiGas™ only)
. Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane,
Sevoflurane, and Nitrous Oxide.
The SC9000/SC9015 is capable of performing 12-lead ST Segment analysis.
This device can be connected to third party devices: Siemens SV300™ ventilator, the Baxter Vigilance™ blood gas/continuous cardiac output monitor, Puritan Bennett 7200™, Dräger Evita II™, Evita V™ & Babylog™, and Siemens SV900™ ventilators.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition
The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; and Arrhythmia which is intended for use in the adult population only
MRI Compatibility Statement:
The Siemens SC9000/SC9015 Bedside Monitoring System Enhanced with 12-Lead ST Segment Analysis is not compatible for use in a 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/K974698 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974698: Siemens SC9000/SC9015 Enhanced with 12-Lead ST Segment Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974698
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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