510(k) · Cleared
ClearedSeries 1500 12-Lead Analysis Option
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 Dec 27, 1991 after a 501-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 61 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it.
- Decided
- Dec 27, 1991
- Review
- 501 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly. 4 of the 61 devices in this family, counting this one, have a Class I recall.
- This deviceK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- Descendant · cites it directly · 34 of its ownK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- Descendant · 2 generations on · 33 of its ownK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- Descendant · 3 generations on · 31 of its ownK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 3 generations on · 30 of its ownK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- Descendant · cites it directly · 24 of its ownK973486 Life Pak 12Physio-Control Corp. · 1998 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K973403Cardiosmart STMarquette Medical Systems, Inc. · 1998 · cites it directly34descendants
- K991014Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999 · 2 generations on33descendants
- K023380T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002 · 3 generations on31descendants
- K031561Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003 · 3 generations on30descendants
- K973486Life Pak 12Physio-Control Corp. · 1998 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| +1 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| +2 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| +3 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| +3 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| +1 | K973486 | Life Pak 12 | Physio-Control Corp. | 1998 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 1 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 1 |
| 2013 | 4 | 1 |
| 2014 | 5 | 1 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (60)
See all 602 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K973403 (Marquette Medical Systems, Inc., 1998) has gone furthest, with 34 descendants of its own.
https://510kreport.com/device/K903644 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903644: Series 1500 12-Lead Analysis Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903644
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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