510(k) · Cleared
ClearedEli 200+ Audicor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DPS Electrocardiograph
Cleared on Jul 25, 2003 as substantially equivalent to K920626 (Mortara Instrument, Inc., 1992) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1992. 44 later devices descend from it.
- Decided
- Jul 25, 2003
- Review
- 101 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920626 (1992). 2 ancestors in all. 44 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- This deviceK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK031517 Zargis Acoustic CardioscanZargis Medical Corp. · 2004
- Descendant · 2 generations on · 15 of its ownK060197 Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006
- Descendant · 2 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 3 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- Descendant · cites it directly · 13 of its ownK032145 Audicor Upgrade SystemInovise Medical, Inc. · 2003
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K031517Zargis Acoustic CardioscanZargis Medical Corp. · 2004 · cites it directly19descendants
- K060197Zargis Acoustic Cardioscan (Zac), Model Zac 6.28Zargis Medical Corp. · 2006 · 2 generations on15descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 2 generations on14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 3 generations on13descendants
- K032145Audicor Upgrade SystemInovise Medical, Inc. · 2003 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| 0 (this device) | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| +1 | K031517 | Zargis Acoustic Cardioscan | Zargis Medical Corp. | 2004 | — |
| +2 | K060197 | Zargis Acoustic Cardioscan (Zac), Model Zac 6.28 | Zargis Medical Corp. | 2006 | — |
| +2 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +3 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| +1 | K032145 | Audicor Upgrade System | Inovise Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K920626 | Model Eli 200 ElectrocardiographSummary page 1…ent texl nology evolutiorl of the Mortara ELI 200 and is substantially equivalent to these legally marketed predic>atedevices: ELI 200 by Mortara Instrument (K920626) Inovlse's Cardiovise Interpretive Software (K001349) HP's 1514A ECGlPhono System The proposed ELI 20… | 1992 |
| * | K001349 | Cardiovise Ecg Interpretative SoftwareSummary page 1…lly equivalent to these legally marketed predic>atedevices: ELI 200 by Mortara Instrument (K920626) Inovlse's Cardiovise Interpretive Software (K001349) HP's 1514A ECGlPhono System The proposed ELI 200+ Audicor is a direct evolution of this Mortara predicate d rvice.… | 2000 |
| * | — | 1514A ECG/Phono System Named without a submission number |
What descends from it? (44)
See all 445 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?
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The ELI 200+ with Audicor is a resting electrocardiograph that provides simultaneous 12-lead ECG acquisition and heart sound data (COR - Correlated Audioelectric Cardiography). The ELI 200+ Audicor Option Electrocardiograph is intended to acquire, record and then store acquired cardiac data of symptomatic patients. The ELI 200+ Audicor Option can also be used to acquire both 12-lead ECG and heart sound data at the same time. The cardiac data is reviewed…
Read the full statement (273 words)
The ELI 200+ with Audicor is a resting electrocardiograph that provides simultaneous 12-lead ECG acquisition and heart sound data (COR - Correlated Audioelectric Cardiography).
The ELI 200+ Audicor Option Electrocardiograph is intended to acquire, record and then store acquired cardiac data of symptomatic patients. The ELI 200+ Audicor Option can also be used to acquire both 12-lead ECG and heart sound data at the same time. The cardiac data is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with LVH, Acute and Age Undetermined MI and detection of S3/S4 Heart Sounds. The S3 and S4 Heart Sounds are useful in the identification of cardiac conditions associated with Left Ventricular dysfunction.
This device is appropriate for the indications listed below:
The device is indicated for use to acquire, analyze, display and print ECG and heart sound (COR) data.
The device is indicated for use to provide interpretation of the data for consideration by physicians.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG and heart sound data (COR) offered by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data.
The device is indicated for use on adult populations, typically symptomatic.
The device is not intended to be used as a vital signs physiological monitor.
Evaluation of cardiac conditions such as LVH, Acute and Age Undetermined MI and detection of S3 and S4 heart sounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031182: Eli 200+ Audicor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031182
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026