510(k) · Cleared
ClearedSiemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg)
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 May 19, 1998 as substantially equivalent to K915225 (Siemens Burdick, Inc., 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 23 later devices descend from it.
- Decided
- May 19, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915225 (1992). 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK915225 MegacartSiemens Burdick, Inc. · 1992
- This deviceK980625 Siemens Multiview Workstation Enhanced with Diagnostic Statements…Siemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- Descendant · 3 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 7 of its ownK030738 Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K031970Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003 · cites it directly14descendants
- K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · 2 generations on13descendants
- K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 2 generations on8descendants
- K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 3 generations on7descendants
- K030738Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly7descendants
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) | K980625 | Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg) | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +2 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| +2 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| +3 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| +1 | K030738 | Siemens Multiview Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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…tion™ Enhanced with Diagnostic Statements (Rest ECG) 3. Predicate Device Identification: Siemens MEGACART™ granted SE (substantial equivalence) under 510(k) file number K915225) 4. Device Description: The Siemens MultiView (SC3000) WorkStation™ enhanced with Diagnostic Statements (Rest ECG) is a modifie… | 1992 |
What descends from it? (23)
See all 233 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?
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 connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability. This device is intended for use with adults…
Read the full statement (111 words)
This device is capable of connecting to one or more bedside monitors via a network. The device allows the user to monitor the patients connected to these monitors at a central location. The monitoring ability of the device is determined by the bedside monitors. In addition, this device can provide interpretive diagnostic statements and reports when connected to a bedside monitor with ECG monitoring capability.
This device is intended for use with adults and pediatrics in an 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.
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/K980625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980625: Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest Ecg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980625
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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