510(k) · Cleared
ClearedMortara Eli 10 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 Mar 15, 2007 as substantially equivalent to K851702 (Mortara Instrument, Inc., 1985) after a 17-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Mar 15, 2007
- Review
- 17 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851702 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK851702 Mortara Instrument Model EL-1Mortara Instrument, Inc. · 1985
- This deviceK070539 Mortara Eli 10 ElectrocardiographMortara Instrument, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK102206 Eli 10 Electrocardiograph Model Eli 10Mortara Instrument, Inc. · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K102206Eli 10 Electrocardiograph Model Eli 10Mortara Instrument, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851702 | Mortara Instrument Model EL-1 | Mortara Instrument, Inc. | 1985 | — |
| 0 (this device) | K070539 | Mortara Eli 10 Electrocardiograph | Mortara Instrument, Inc. | 2007 | — |
| +1 | K102206 | Eli 10 Electrocardiograph Model Eli 10 | Mortara Instrument, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K851702 | Mortara Instrument Model EL-1Summary page 1…aph is a current technology evolution of the Mortara EL-i and is substantially equivalent to the legally marketed predicate device: * EL-i by Mortara Instrument (K851 702) The proposed ELI 10 is the evolutionary market replacement of this Mortara predicate device. Description: The proposed ELI 10 w… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102206 | Eli 10 Electrocardiograph Model Eli 10 | 2011 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K102206 (Mortara Instrument, Inc., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 device is indicated for use to acquire, analyze, display and print electrocardiograms. (printing function available only through an external, optional printer) The device is indicated for use to provide interpretation of the data for consideration by a physician. 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…
Read the full statement (145 words)
The device is indicated for use to acquire, analyze, display and print electrocardiograms. (printing function available only through an external, optional printer)
The device is indicated for use to provide interpretation of the data for consideration by a physician.
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 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 on adult populations.
The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-channel ECGs.
The device is not intended to be used as a vital signs physiological monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070539 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070539: Mortara Eli 10 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070539
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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