510(k) · Cleared
Recalled · Class II · 2020Eli PC Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · DPS Electrocardiograph
Cleared on Feb 19, 2010 as substantially equivalent to K082946 (Mortara Instrument, Inc., 2008) and 1 other predicate after a 116-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 19, 2010
- Review
- 116 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933143 (1994). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 2 generations backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
- 1 generation backK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
- This deviceK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK120865 Rscribe ElectrocardiographMortara Instrument, Inc. · 2012 · Recalled
- Descendant · cites it directly · 2 of its ownK110065 Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK150564 Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC · 2015
- Descendant · 2 generations on · 0 of its ownK260250 QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph…QT Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK163607 ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120865Rscribe ElectrocardiographMortara Instrument, Inc. · 2012 · cites it directly2descendants
- K110065Spaulding IQ ElectrocardiographSpaulding Clinical Research, LLC · 2011 · cites it directly2descendants
- K150564Spaulding Electrocardiograph 2100iQSpaulding Clinical Research, LLC · 2015 · 2 generations on1descendant
- K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026 · 2 generations on0descendants
- K163607ECG Acquisition SystemsVales & Hills Biomedical Tech., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −2 | K062677 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2006 | — |
| −1 | K082946 | Mortara Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2008 | — |
| 0 (this device) | K093339 | Eli PC Electrocardiograph | Mortara Instrument, Inc. | 2010 | — |
| +1 | K120865 | Rscribe Electrocardiograph | Mortara Instrument, Inc. | 2012 | 1 |
| +1 | K110065 | Spaulding IQ Electrocardiograph | Spaulding Clinical Research, LLC | 2011 | — |
| +2 | K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | 2015 | — |
| +2 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026 | — |
| +3 | K163607 | ECG Acquisition Systems | Vales & Hills Biomedical Tech., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K082946 | Mortara Eli 350 ElectrocardiographSummary page 1…Instruments ELI PC is substantially equivalent to the legally marketed devices presently in distribution: * Mortara Instrument ELI 350 Electrocardiograph (K082946) * Midmark Brentwood lQmark-ECG Analysis System (K955023) DescriptIon: The proposed Mortara Instrument ELI PC utili… | 2008 |
| * | K955023 | Brentwood PC-EcgSummary page 1…d devices presently in distribution: * Mortara Instrument ELI 350 Electrocardiograph (K082946) * Midmark Brentwood lQmark-ECG Analysis System (K955023) DescriptIon: The proposed Mortara Instrument ELI PC utilizes previously approved predicate Mortara legacy technology and design… | 1997 |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2020 | Class II | Z-1811-2020 | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K120865 (Mortara Instrument, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K082946.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 PC Electrocardiograph is a non-invasive prescription device * The proposed Mortara ELI-PC Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. * The device is indicated for use for patients of any age, diseased or non-diseased. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * The interpretations of ECG offered by the device are only…
Read the full statement (208 words)
The ELI PC Electrocardiograph is a non-invasive prescription device
* The proposed Mortara ELI-PC Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms.
* The device is indicated for use for patients of any age, diseased or non-diseased.
* The device is indicated for use to provide interpretation of the data for consideration by a physician.
* The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
* The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
* The device is not intended to be used as a vital signs physiological monitor.
* It is not designed for out of hospital transport.
* It is not designed for use in highly invasive environments, such as an operating theatre.
* The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093339: Eli PC Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093339
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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