510(k) · Cleared
ClearedModel Eli 200 Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Sep 4, 1992 after a 219-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 45 later devices descend from it.
- Decided
- Sep 4, 1992
- Review
- 219 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 2 citing it directly.
- This deviceK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- Descendant · cites it directly · 44 of its ownK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- Descendant · 2 generations on · 19 of its ownK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- Descendant · 3 generations on · 15 of its ownK060197 Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006
- Descendant · 3 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 4 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K031182Eli 200+ AudicorMortara Instrument, Inc. · 2003 · cites it directly44descendants
- K031517Zargis Acoustic CardioscanZargis Medical Corp. · 2004 · 2 generations on19descendants
- K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006 · 3 generations on15descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 3 generations on14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| +1 | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| +2 | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| +3 | K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 | Zargis Medical Corp. | 2006 | — |
| +3 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +4 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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.
Planning a device in LOS? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (45)
See all 452 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031182 (Mortara Instrument, Inc., 2003) has gone furthest, with 44 descendants of its own.
https://510kreport.com/device/K920626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920626: Model Eli 200 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920626
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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