510(k) · Cleared
Cleared1481 T Digital Telemetry System with S-T Segment Analysis Option
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 Oct 4, 1995 after a 191-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 42 later devices descend from it.
- Decided
- Oct 4, 1995
- Review
- 191 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
42 later devices descend from it, 3 citing it directly.
- This deviceK951371 1481 T Digital Telemetry System with S-T Segment Analysis OptionSiemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 37 of its ownK972714 Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · 2 generations on · 36 of its ownK983980 Siemens Multiview Infinity Telemetry System Enhancement, Additional…Siemens Medical Solutions USA, Inc. · 1998
- Descendant · 2 generations on · 35 of its ownK024108 Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 3 generations on · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
- Descendant · 4 generations on · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K972714Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 1997 · cites it directly37descendants
- K983980Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia CallsSiemens Medical Solutions USA, Inc. · 1998 · 2 generations on36descendants
- K024108Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on35descendants
- K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007 · 3 generations on26descendants
- K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K983980 | Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia… | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +2 | K024108 | Siemens Multi View Infinity Telemetry System | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +3 | K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | 2007 | — |
| +4 | K130711 | Infinity Centralstation with Infinity M300 | Draeger Medical Systems, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (42)
See all 423 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?
- Of its descendants, K972714 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 37 descendants of its own.
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 | — |
https://510kreport.com/device/K951371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951371: 1481 T Digital Telemetry System with S-T Segment Analysis Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951371
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026