510(k) · Cleared
ClearedSiemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia Calls
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 Nov 16, 1998 as substantially equivalent to K972714 (Siemens Medical Solutions USA, Inc., 1997) after a 7-day review. Its family tree reaches back 2 generations to 1995. 36 later devices descend from it.
- Decided
- Nov 16, 1998
- Review
- 7 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951371 (1995). 36 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951371 1481 T Digital Telemetry System with S-T Segment Analysis OptionSiemens Medical Solutions USA, Inc. · 1995
- 1 generation backK972714 Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 1997
- This deviceK983980 Siemens Multiview Infinity Telemetry System Enhancement, Additional…Siemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 35 of its ownK024108 Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 2 generations on · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
- Descendant · 3 generations on · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 23 of its ownK151860 Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K024108Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002 · cites it directly35descendants
- K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
- K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · 3 generations on25descendants
- K151860Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · 4 generations on23descendants
- K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951371 | 1481 T Digital Telemetry System with S-T Segment Analysis Option | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −1 | K972714 | Siemens Multiview Workstation Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K983980 | Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia… | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K024108 | Siemens Multi View Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +2 | K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | 2007 | — |
| +3 | K130711 | Infinity Centralstation with Infinity M300 | Draeger Medical Systems, Inc. | 2013 | 2 |
| +4 | K151860 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2015 | 2 |
| +5 | K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple… | Snap40, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K972714 | Siemens Multiview Workstation Infinity Telemetry SystemSummary page 1…evice Identification: Siemens MultiView WorkStation Infinity Telemetry System Description of Modification: The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls. Intended Use: (Same as K972714) Biocompa… | 1997 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024108 | Siemens Multi View Infinity Telemetry System | 2002 | 35 |
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 3 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K024108 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K972714.
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?
Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters: Heart rate ECG Arrhythmia Analysis Arterial oxygen saturation Pulse rate…
Read the full statement (112 words)
Use of the MultiView WorkStation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
Heart rate
ECG Arrhythmia Analysis
Arterial oxygen saturation
Pulse rate
ST segment analysis
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.
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/K983980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983980: Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia Calls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983980
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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