510(k) · Cleared
ClearedMarquette Eagle Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 19, 1994 after a 788-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 237 devices in its family, counting itself, have a Class I recall. 236 later devices descend from it.
- Decided
- Apr 19, 1994
- Review
- 788 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
236 later devices descend from it, 2 citing it directly. 4 of the 237 devices in this family, counting this one, have a Class I recall.
- This deviceK920790 Marquette Eagle MonitorMarquette Electronics, Inc. · 1994
- Descendant · cites it directly · 122 of its ownK960418 Eagle Patient MonitorMarquette Electronics, Inc. · 1996
- Descendant · 2 generations on · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- Descendant · cites it directly · 115 of its ownK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- Descendant · 3 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 4 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
Showing 5 of 236 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 236 · See all- K960418Eagle Patient MonitorMarquette Electronics, Inc. · 1996 · cites it directly122descendants
- K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · 2 generations on119descendants
- K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997 · cites it directly115descendants
- K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 3 generations on88descendants
- K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920790 | Marquette Eagle Monitor | Marquette Electronics, Inc. | 1994 | — |
| +1 | K960418 | Eagle Patient Monitor | Marquette Electronics, Inc. | 1996 | — |
| +2 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| +1 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| +3 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +4 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 12 | 1 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 13 | 0 |
| 2010 | 16 | 0 |
| 2011 | 12 | 0 |
| 2012 | 9 | 1 |
| 2013 | 15 | 1 |
| 2014 | 14 | 1 |
| 2015 | 13 | 0 |
| 2016 | 13 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 7 | 0 |
| 2024 | 11 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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.
4 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 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? (236)
See all 2362 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 6 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K960418 (Marquette Electronics, Inc., 1996) has gone furthest, with 122 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/K920790 · printed Nov 4, 2026
Cite this page
510(k) Report. “K920790: Marquette Eagle Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920790
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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