510(k) · Cleared
ClearedSiemens Sirecust 1481T, Digital Telemetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Electronics · DSI Detector And Alarm, Arrhythmia
Cleared on Jun 28, 1990 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.
- Decided
- Jun 28, 1990
- Review
- 156 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 1 citing it directly.
- This deviceK900319 Siemens Sirecust 1481T, Digital Telemetry SystemSiemens Medical Electronics · 1990
- Descendant · cites it directly · 39 of its ownK970999 Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems · 1997
- Descendant · 2 generations on · 38 of its ownK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- Descendant · 2 generations on · 33 of its ownK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- Descendant · 3 generations on · 31 of its ownK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- Descendant · 4 generations on · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K970999Sony PGM-100P1MD Trinitron Color Graphic MonitorSony Medical Systems · 1997 · cites it directly39descendants
- K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998 · 2 generations on38descendants
- K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998 · 2 generations on33descendants
- K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004 · 3 generations on31descendants
- K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900319 | Siemens Sirecust 1481T, Digital Telemetry System | Siemens Medical Electronics | 1990 | — |
| +1 | K970999 | Sony PGM-100P1MD Trinitron Color Graphic Monitor | Sony Medical Systems | 1997 | — |
| +2 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| +2 | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| +3 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| +4 | K042755 | Monochrome LCD Monitor, Radiforce G51 | Eizo Nanao Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970999 | Sony PGM-100P1MD Trinitron Color Graphic Monitor | 1997 | 39 |
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, K970999 (Sony Medical Systems, 1997) has gone furthest, with 39 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/K900319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900319: Siemens Sirecust 1481T, Digital Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900319
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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