510(k) · Cleared
ClearedEagle 3000/3100 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · MLD Monitor, St Segment With Alarm
Cleared on Oct 2, 1996 as substantially equivalent to K904789 (Marquette Electronics, Inc., 1991) after a 258-day review. Its family tree reaches back 1 generation to 1991. 121 later devices descend from it.
- Decided
- Oct 2, 1996
- Review
- 258 days
- Class
- Class II
- Product code
- MLD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K904789 (1991). 121 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904789 Series 7000 Carbon Dioxide ModuleMarquette Electronics, Inc. · 1991
- This deviceK960272 Eagle 3000/3100 Patient MonitorMarquette Electronics, Inc. · 1996
- Descendant · cites it directly · 119 of its ownK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- Descendant · 2 generations on · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 3 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- Descendant · 2 generations on · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- Descendant · 4 generations on · 71 of its ownK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
Showing 5 of 121 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 121 · See all- K993531Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · cites it directly119descendants
- K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · 2 generations on88descendants
- K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 3 generations on87descendants
- K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · 2 generations on75descendants
- K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 4 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904789 | Series 7000 Carbon Dioxide Module | Marquette Electronics, Inc. | 1991 | — |
| 0 (this device) | K960272 | Eagle 3000/3100 Patient Monitor | Marquette Electronics, Inc. | 1996 | — |
| +1 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| +2 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +3 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +2 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| +4 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 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.
Planning a device in MLD? 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K920790 | FDA’s K920790 is Marquette Eagle Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1994 |
| Kept off the family tree | K952474 | FDA’s K952474 is Eagle 3000 Patient Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1995 |
| * | K904789 | Series 7000 Carbon Dioxide Module Our OCR of the scanned summary read K504789, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Carbon Dioxide Module”. | 1991 |
What descends from it? (121)
See all 1212 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?
- Its one ancestor has no recall.
- Of its descendants, K993531 (Datascope Corp., 2000) has gone furthest, with 119 descendants of its own.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLD
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MLD
Too few MLD 510(k)s in any year since 2007 to give a median.
Recalls per year · MLD
No recall names MLD since 2007.
Adverse event reports per year · MLD
1in 2019
MAUDE reports naming product code MLD, 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 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Marquette Eagle 3000 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 the printing of information by a paper recorder. Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal. Use of the…
Read the full statement (185 words)
The Marquette Eagle 3000 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 the printing of information by a paper recorder.
Use of the Marquette Eagle 3000 Patient Monitor is intended for patient populations including: adult, pediatric, and/or neonatal.
Use of the Marquette Eagle 3000 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 3000 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/K960272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960272: Eagle 3000/3100 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960272
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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