510(k) Report

510(k) · Cleared

Cleared

12SSL-SC

K842308510(k) TraditionalCleared Sep 21, 1984101-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 Sep 21, 1984 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 62 later devices descend from it.

Decided
Sep 21, 1984
Review
101 days
Product code
LOS
Recalls
None
Predicates
0

62 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 6 descendants cleared1998: 1 descendant cleared2020: 3 descendants cleared2018: 4 descendants cleared1999: 1 descendant cleared2025: 4 descendants cleared2024: 3 descendants cleared2022: 3 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2006: 3 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2014: 4 descendants cleared2015: 4 descendants cleared2012: 5 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2013: 4 descendants cleared2017: 2 descendants cleared2021: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared19801990200020102020
  1. This deviceK842308 12SSL-SCMarquette Electronics, Inc. · 1984
  2. Descendant · cites it directly · 61 of its ownK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
  3. Descendant · 2 generations on · 60 of its ownK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
  4. Descendant · 3 generations on · 23 of its ownK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
  5. Descendant · 4 generations on · 22 of its ownK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
  6. Descendant · 3 generations on · 20 of its ownK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 12003: 12004: 12005: 22006: 32007: 12008: 22009: 12010: 12011: 22012: 52013: 42014: 42015: 42016: 62017: 22018: 42020: 32021: 12022: 32023: 12024: 32025: 42026: 1
1998high 6 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 62 · See all
  • K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998 · cites it directly61descendants
  • K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · 2 generations on60descendants
  • K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002 · 3 generations on23descendants
  • K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies · 2004 · 4 generations on22descendants
  • K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · 3 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K84230812SSL-SCMarquette Electronics, Inc.1984—
+1K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc.1998—
+2K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn19991
+3K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn2002—
+4K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital…Ge Medical Systems Information Technologies20043
+3K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200310
200410
200520
200630
200710
200820
200910
201010
201120
201250
201340
201440
201540
201660
201720
201840
202030
202110
202230
202310
202430
202540
202610
FIG. 1 — Lineage of K842308, 1984–2026Source: 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.

Planning a device in LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc.199861
K162012CARESCAPE Central Station V2GE Healthcare20167

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?

  • Of its descendants, K980495 (Marquette Medical Systems, Inc., 1998) has gone furthest, with 61 descendants of its own.
Cite this page

510(k) Report. “K842308: 12SSL-SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842308

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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