510(k) · Cleared
ClearedEagle 4000 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Feb 21, 1997 as substantially equivalent to K920790 (Marquette Electronics, Inc., 1994) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1993. 4 of the 118 devices in its family, counting itself, have a Class I recall. 115 later devices descend from it.
- Decided
- Feb 21, 1997
- Review
- 87 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921669 (1993). 2 ancestors in all. 115 later devices descend from it, 6 citing it directly. 4 of the 118 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- This deviceK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- Descendant · cites it directly · 81 of its ownK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- Descendant · 2 generations on · 71 of its ownK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 3 generations on · 32 of its ownK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 31 of its ownK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- Descendant · 4 generations on · 30 of its ownK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 115 · See all- K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8…General Electric Medical Systems Information Techn · 1999 · cites it directly81descendants
- K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on71descendants
- K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc. · 2009 · 3 generations on32descendants
- K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003 · 3 generations on31descendants
- K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| 0 (this device) | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| +1 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| +2 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| +3 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| +3 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| +4 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 1 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 1 |
| 2013 | 8 | 1 |
| 2014 | 8 | 1 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 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.
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K920790 | Marquette Eagle MonitorSummary page 2…ially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution: Marquette Eagle Monitor K920790 Marquette SL Series Tram Module K921669 4. Device Description The Marquette Eagle 4000 Patient Monitor is a patient monitoring s… | 1994 |
| * | K921669 | Marquette SL Series Transport Remote AcquisitionSummary page 2…ns for use to the following devices which are currently legally marketed and in commercial distribution: Marquette Eagle Monitor K920790 Marquette SL Series Tram Module K921669 4. Device Description The Marquette Eagle 4000 Patient Monitor is a patient monitoring system that is designed to be used to mon… | 1993 |
What descends from it? (115)
See all 1156 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8… | 1999 | 81 |
| K973486 | Life Pak 12 | 1998 | 24 |
| K060307 | 12 RL Algorithm | 2006 | 5 |
| K160667 | Anybattery C2 Rechargeable Battery | 2017 | 0 |
| K070232 | Ecg Cables, Trunk and Patient Lead Wires | 2007 | 0 |
| K971683 | Wireless Lan (Local Area Network) - Wireless Ethernet | 1997 | 0 |
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 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 5 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 · 5 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
What is it indicated for?
The Marquette Eagle 4000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs. The option is provided for printing of information by a paper recorder. Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal. Use of the Marquette…
Read the full statement (185 words)
The Marquette Eagle 4000 Patient Monitor is designed to monitor and display patient data. Its design allows the operator to adjust parameter alarm settings that would audibly and visually notify the operator when a violation occurs.
The option is provided for printing of information by a paper recorder.
Use of the Marquette Eagle 4000 Patient Monitor is intended for patient populations including: adult, pediatric, and/ or neonatal.
Use of the Marquette Eagle 4000 Patient Monitor is not recommended for use in patient's home or residence, during patient transport, or when it has not been ordered by a physician or other qualified medical personnel.
Use of the Marquette Eagle 4000 Patient Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.
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/K964750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964750: Eagle 4000 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964750
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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