510(k) · Cleared
Recalled · Class II · 2020Eli 350 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 Dec 14, 2009 as substantially equivalent to K082946 (Mortara Instrument, Inc., 2008) and 2 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1993. It has been recalled once.
- Decided
- Dec 14, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K921669 (1993). 18 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 4 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 3 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 2 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 1 generation backK073625 Modification to: Mac 5500 Resting Ecg Analysis SystemGe Healthcare Systems Information Technologies · 2008
- This deviceK092663 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −4 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −3 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −2 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −1 | K073625 | Modification to: Mac 5500 Resting Ecg Analysis System | Ge Healthcare Systems Information Technologies | 2008 | — |
| 0 (this device) | K092663 | Eli 350 Electrocardiograph | Mortara Instrument, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K082946 | Mortara Eli 350 ElectrocardiographSummary page 1…iograph expands the capability of the Mortars ELI 350 and is substantially equivalent to the legally marketed predicate devices: * ELI 350 by Mortara Instrument (K082946) * X-Scribe Stress Exercise Testing System (K022618) * MAC 5500 Resting ECG Analysis System (K(073625) The propos… | 2008 |
| * | K022618 | X-Scribe IISummary page 1…substantially equivalent to the legally marketed predicate devices: * ELI 350 by Mortara Instrument (K082946) * X-Scribe Stress Exercise Testing System (K022618) * MAC 5500 Resting ECG Analysis System (K(073625) The proposed ELI 350 is a modification of the Mortars ELI 350 predicat… | 2002 |
| * | K073625 | Modification to: Mac 5500 Resting Ecg Analysis SystemSummary page 1…devices: * ELI 350 by Mortara Instrument (K082946) * X-Scribe Stress Exercise Testing System (K022618) * MAC 5500 Resting ECG Analysis System (K(073625) The proposed ELI 350 is a modification of the Mortars ELI 350 predicate device with inclusion of the stress exercise intended us… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 18 ancestors has a recall.
- 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. 2009, 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. 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…
Read the full statement (169 words)
The device is indicated for use to acquire, analyze, display and print electrocardiograms.
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 and pediatric populations.
The device is not intended to be used as a vital signs physiological monitor.
The device is indicated for use to acquire, analyze, display and print signal-averaged ECGs to detect ventricular late potentials for consideration by a physician.
The device is indicated for use to acquire, process, record, archive, analyze, display and print ECG data of patients undergoing physiologic stress exercise testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092663 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092663: Eli 350 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092663
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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