510(k) Report

510(k) · Cleared

Cleared

Eagle 3000 Patient Monitor

K952474510(k) TraditionalCleared Oct 19, 1995142-day reviewClass II21 CFR 870.2300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Marquette Electronics, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Oct 19, 1995 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 351 devices in its family, counting itself, has a Class I recall. 350 later devices descend from it.

Decided
Oct 19, 1995
Review
142 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
0

350 later devices descend from it, 5 citing it directly. 1 of the 351 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 3 descendants cleared1996: 1 descendant cleared2003: 3 descendants cleared2006: 9 descendants cleared2004: 3 descendants cleared2007: 7 descendants cleared2008: 6 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared2011: 10 descendants cleared2010: 17 descendants cleared2009: 15 descendants cleared2016: 17 descendants cleared2018: 18 descendants cleared2002: 1 descendant cleared2012: 17 descendants cleared2013: 18 descendants cleared2015: 15 descendants cleared2014: 22 descendants cleared, 1 with a Class I recall12022: 28 descendants cleared2017: 15 descendants cleared2019: 19 descendants cleared2020: 15 descendants cleared2021: 13 descendants cleared2023: 19 descendants cleared2024: 22 descendants cleared2026: 16 descendants cleared2025: 19 descendants cleared1995200020052010201520202025
  1. This deviceK952474 Eagle 3000 Patient MonitorMarquette Electronics, Inc. · 1995
  2. Descendant · cites it directly · 260 of its ownK032867 Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003
  3. Descendant · cites it directly · 259 of its ownK051608 Star 50 Monitoring SystemLarsen & Toubro Limited · 2005
  4. Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  6. Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled

Showing 5 of 350 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12000: 12002: 12003: 32004: 32005: 32006: 92007: 72008: 62009: 152010: 172011: 102012: 172013: 182014: 222015: 152016: 172017: 152018: 182019: 192020: 152021: 132022: 282023: 192024: 222025: 192026: 16
1996high 28 (2022) · low 0 (1997)2026

Class I recalls in this family

  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 350 · See all
  • K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited · 2003 · cites it directly260descendants
  • K051608Star 50 Monitoring SystemLarsen & Toubro Limited · 2005 · cites it directly259descendants
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952474Eagle 3000 Patient MonitorMarquette Electronics, Inc.1995—
+1K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited2003—
+1K051608Star 50 Monitoring SystemLarsen & Toubro Limited2005—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20099

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200010
200210
200330
200430
200530
200690
200770
200860
2009150
2010170
2011100
2012170
2013180
2014221
2015150
2016170
2017150
2018180
2019190
2020150
2021130
2022280
2023190
2024220
2025190
2026160
FIG. 1 — Lineage of K952474, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has 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 DRT device

  1. #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (350)

See all 350

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032867Star (Lunar Series) Monitoring SystemLarsen & Toubro Limited2003260
K051608Star 50 Monitoring SystemLarsen & Toubro Limited2005259
K960418Eagle Patient MonitorMarquette Electronics, Inc.1996122
K032871Planet Monitoring SystemLarsen & Toubro Limited20038
K043370Planet 50 Monitoring SystemLarsen & Toubro Limited20052

Has anything in its family been recalled? (1 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.

  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K032867 (Larsen & Toubro Limited, 2003) has gone furthest, with 260 descendants of its own.

How does its category compare?

All DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRT

1in 2025

2007: 12008: 12009: 62010: 32011: 32012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 32025: 12026 (partial year): 5
2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2009: 70 days median2010: 44 days median2011: 149 days median2024: 228 days median2026 (partial year): 120 days median
2007high 228 (2024) · low 44 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRT

1in 2024

2011: 12021: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRT

40in 2025

2007: 1132008: 992009: 1182010: 632011: 362012: 472013: 162014: 262015: 482016: 552017: 1592018: 2242019: 4472020: 502021: 852022: 352023: 472024: 292025: 40
2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—0113
20081—099
20096700118
2010344063
20113149136
20121—047
20131—016
20140—026
20151—048
20161—055
20171—0159
20181—0224
20191—0447
20200—050
20212—185
20221—035
20231—047
20243228129
20251—040
202651200—

More from Marquette Electronics, Inc.

82 FDA decisions under this applicant name. See the company

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Recent decisions in DRT

The DRT category page

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https://510kreport.com/device/K952474 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952474: Eagle 3000 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952474

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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