510(k) · Cleared
Recalled · Class II · 2020Eli 230 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 Apr 16, 2010 as substantially equivalent to K031182 (Mortara Instrument, Inc., 2003) after an 87-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it. It has been recalled once.
- Decided
- Apr 16, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920626 (1992). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- 1 generation backK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- This deviceK100127 Eli 230 ElectrocardiographMortara Instrument, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK120865 Rscribe ElectrocardiographMortara Instrument, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK161517 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
- 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 ownK173765 Surveyor Patient MonitorMortara Instrument, Inc. · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · cites it directly2descendants
- K120865Rscribe ElectrocardiographMortara Instrument, Inc. · 2012 · cites it directly2descendants
- K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017 · 2 generations on1descendant
- K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026 · 2 generations on0descendants
- K173765Surveyor Patient MonitorMortara Instrument, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| −1 | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| 0 (this device) | K100127 | Eli 230 Electrocardiograph | Mortara Instrument, Inc. | 2010 | — |
| +1 | K123556 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2013 | 1 |
| +1 | K120865 | Rscribe Electrocardiograph | Mortara Instrument, Inc. | 2012 | 1 |
| +2 | K161517 | Mortara Surveyor Patient Monitor | Mortara Instrument, Inc. | 2017 | — |
| +2 | K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026 | — |
| +3 | K173765 | Surveyor Patient Monitor | Mortara Instrument, Inc. | 2018 | 2 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K031182 | Eli 200+ AudicorSummary page 1…ruments ELI 230 Electrocardiograph is substantially equivalent to the legally marketed devices presently in distribution: Mortars Instrument ELI 250 Electrocardiograph (K031 182). Description: The ELI 230 isa multi-channel diagnostic electrocardiograph intended for acquiring,viewing and printing ECG's of… | 2003 |
| † | K082946 | Mortara Eli 350 Electrocardiograph | 2008 |
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-1810-2020 | 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 18 years and passes through 1 company; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K123556 (Mortara Instrument, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K031182.
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 230 Electrocardiograph is a non-invasive prescription device. * The Mortara ELI 230 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…
Read the full statement (181 words)
The ELI 230 Electrocardiograph is a non-invasive prescription device.
* The Mortara ELI 230 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 EGG 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.
* 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/K100127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100127: Eli 230 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100127
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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