510(k) Report

510(k) · Cleared

Cleared

Marquette SL Series Transport Remote Acquisition

K921669510(k) TraditionalCleared May 7, 1993394-day review

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

Marquette Electronics, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on May 7, 1993 after a 394-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 of the 234 devices in its family, counting itself, have a Class I recall. 233 later devices descend from it.

Decided
May 7, 1993
Review
394 days
Product code
LOS
Recalls
None
Predicates
0

233 later devices descend from it, 7 citing it directly. 9 of the 234 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1999: 4 descendants cleared1997: 2 descendants cleared2000: 2 descendants cleared2004: 9 descendants cleared, 1 with a Class I recall11998: 2 descendants cleared2006: 6 descendants cleared, 1 with a Class I recall12017: 10 descendants cleared2007: 7 descendants cleared2003: 5 descendants cleared2002: 3 descendants cleared2015: 13 descendants cleared2014: 15 descendants cleared, 3 with a Class I recall32010: 11 descendants cleared2009: 10 descendants cleared2013: 15 descendants cleared, 1 with a Class I recall12008: 9 descendants cleared, 1 with a Class I recall12011: 11 descendants cleared2012: 9 descendants cleared, 1 with a Class I recall12019: 6 descendants cleared2016: 13 descendants cleared2025: 9 descendants cleared2023: 10 descendants cleared, 1 with a Class I recall12018: 9 descendants cleared2005: 1 descendant cleared2022: 14 descendants cleared2021: 5 descendants cleared2024: 9 descendants cleared2020: 6 descendants cleared2026: 8 descendants cleared1990200020102020
  1. This deviceK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. Descendant · cites it directly · 116 of its ownK993757 SOLAR 7/8000General Electric Medical Systems Information Techn · 2000
  3. Descendant · cites it directly · 115 of its ownK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
  4. Descendant · 2 generations on · 100 of its ownK012467 Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002 · Recalled
  5. Descendant · 2 generations on · 81 of its ownK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
  6. Descendant · 3 generations on · 71 of its ownK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002

Showing 5 of 233 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 42000: 22002: 32003: 52004: 92005: 12006: 62007: 72008: 92009: 102010: 112011: 112012: 92013: 152014: 152015: 132016: 132017: 102018: 92019: 62020: 62021: 52022: 142023: 102024: 92025: 92026: 8
1997high 15 (2013) · low 0 (2001)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 233 · See all
  • K993757SOLAR 7/8000General Electric Medical Systems Information Techn · 2000 · cites it directly116descendants
  • K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997 · cites it directly115descendants
  • K012467Solar 8000M SystemGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on100descendants
  • K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8…General Electric Medical Systems Information Techn · 1999 · 2 generations on81descendants
  • K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002 · 3 generations on71descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921669Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc.1993—
+1K993757SOLAR 7/8000General Electric Medical Systems Information Techn2000—
+1K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997—
+2K012467Solar 8000M SystemGeneral Electric Medical Systems Information Techn20022
+2K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac…General Electric Medical Systems Information Techn1999—
+3K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199940
200020
200230
200350
200491
200510
200661
200770
200891
2009100
2010110
2011110
201291
2013151
2014153
2015130
2016130
2017100
201890
201960
202060
202150
2022140
2023101
202490
202590
202680
FIG. 1 — Lineage of K921669, 1993–2026Source: 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.

9 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (233)

See all 233

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

NumberDeviceApplicantDecidedDescendants
K993757SOLAR 7/8000General Electric Medical Systems Information Techn2000116
K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997115
K993826Narkomed 6000Draeger Medical, Inc.200016
K033498Narkomed 6400, Model NM6400Draeger Medical, Inc.200415
K990068Solar 9500 Information MonitorGeneral Electric Medical Systems Information Techn19992
K992929Dash 3000 Patient MonitorGeneral Electric Medical Systems Information Techn19990
K982728Nellcor Puritan Bennett Uniprobe Adapter Cable, UP12A, UP12B, UP12CNellcor Puritan Bennett, Inc.19980

Has anything in its family been recalled? (9 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 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
  • 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
  • K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
  • K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
  • K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
  • K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 5 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
  • 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
  • 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, K993757 (General Electric Medical Systems Information Techn, 2000) has gone furthest, with 116 descendants of its own.
Cite this page

510(k) Report. “K921669: Marquette SL Series Transport Remote Acquisition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K921669

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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