510(k) · Cleared
ClearedMax-1 (Exercise Electrocardiograph)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jun 16, 1989 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 72 later devices descend from it.
- Decided
- Jun 16, 1989
- Review
- 144 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
72 later devices descend from it, 1 citing it directly.
- This deviceK890323 Max-1 (Exercise Electrocardiograph)Marquette Electronics, Inc. · 1989
- Descendant · cites it directly · 71 of its ownK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 2 generations on · 32 of its ownK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 31 of its ownK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- Descendant · 3 generations on · 30 of its ownK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- Descendant · 4 generations on · 21 of its ownK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002 · cites it directly71descendants
- K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Edan Instruments, Inc. · 2009 · 2 generations on32descendants
- K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003 · 2 generations on31descendants
- K042177Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004 · 3 generations on30descendants
- K06083312SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890323 | Max-1 (Exercise Electrocardiograph) | Marquette Electronics, Inc. | 1989 | — |
| +1 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| +2 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| +2 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| +3 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| +4 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
Planning a device in DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (72)
See all 721 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014108 | Mac 5000 Ecg Analysis System | 2002 | 71 |
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, K014108 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 71 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
https://510kreport.com/device/K890323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K890323: Max-1 (Exercise Electrocardiograph).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K890323
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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