510(k) · Cleared
ClearedTramscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DPS Electrocardiograph
Cleared on Apr 26, 1990 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 435 devices in its family, counting itself, have a Class I recall. 434 later devices descend from it.
- Decided
- Apr 26, 1990
- Review
- 77 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
434 later devices descend from it, 4 citing it directly. 5 of the 435 devices in this family, counting this one, have a Class I recall.
- This deviceK900598 Tramscope SystemMarquette Electronics, Inc. · 1990
- Descendant · cites it directly · 299 of its ownK955059 Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996
- Descendant · 2 generations on · 292 of its ownK013515 Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 3 generations on · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
- Descendant · 4 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
- Descendant · 5 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
Showing 5 of 434 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 434 · See all- K955059Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 RecorderSiemens Medical Solutions USA, Inc. · 1996 · cites it directly299descendants
- K013515Infinity ExplorerSiemens Medical Solutions USA, Inc. · 2002 · 2 generations on292descendants
- K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · 3 generations on289descendants
- K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 4 generations on280descendants
- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 5 generations on251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900598 | Tramscope System | Marquette Electronics, Inc. | 1990 | — |
| +1 | K955059 | Olympus Comm. NTWK., SC 3000 WKST. & Remote Display, R 100 Recorder | Siemens Medical Solutions USA, Inc. | 1996 | — |
| +2 | K013515 | Infinity Explorer | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +3 | K022889 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &… | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +4 | K031340 | Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with… | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +5 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 1 |
| 2005 | 10 | 0 |
| 2006 | 15 | 0 |
| 2007 | 13 | 0 |
| 2008 | 9 | 1 |
| 2009 | 14 | 0 |
| 2010 | 18 | 0 |
| 2011 | 14 | 0 |
| 2012 | 16 | 0 |
| 2013 | 20 | 0 |
| 2014 | 19 | 2 |
| 2015 | 18 | 0 |
| 2016 | 17 | 0 |
| 2017 | 19 | 0 |
| 2018 | 20 | 0 |
| 2019 | 17 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 30 | 0 |
| 2023 | 28 | 1 |
| 2024 | 21 | 0 |
| 2025 | 23 | 0 |
| 2026 | 20 | 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.
5 devices in this family have a Class I recall. 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (434)
See all 4344 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133886Perseus A500Draeger Medical GmbH · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 5 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 6 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K955059 (Siemens Medical Solutions USA, Inc., 1996) has gone furthest, with 299 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
https://510kreport.com/device/K900598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900598: Tramscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900598
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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