510(k) Report

510(k) · Cleared

Cleared

Mortara Eli 350 Electrocardiograph

K082946510(k) TraditionalCleared Dec 29, 200888-day reviewClass II21 CFR 870.2340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mortara Instrument, Inc. · DPS Electrocardiograph

Cleared on Dec 29, 2008 as substantially equivalent to K062677 (Mortara Instrument, Inc., 2006) after an 88-day review. Its family tree reaches back 2 generations to 1994. 25 later devices descend from it.

Decided
Dec 29, 2008
Review
88 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K933143 (1994). 25 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2013: 1 descendant cleared2010: 3 descendants cleared2009: 1 descendant cleared2014: 3 descendants cleared2012: 2 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2015: 1 descendant cleared2026: 2 descendants cleared2017: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant clearedK933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 1994K062677 · Eli 350 Electrocardiograph · Mortara Instrument, Inc. · 20061990200020102020
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K062677 · Eli 350 Electrocardiograph · Mortara Instrument, Inc. · 2006K933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 19940+5
  1. Root · 2 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
  2. 1 generation backK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
  3. This deviceK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
  4. Descendant · cites it directly · 6 of its ownK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
  5. Descendant · cites it directly · 6 of its ownK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
  6. Descendant · cites it directly · 4 of its ownK142105 Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK173830 MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · Recalled
  8. Descendant · 2 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2009: 12010: 32011: 22012: 22013: 12014: 32015: 12016: 22017: 22018: 22020: 12021: 12022: 22026: 2
2009high 3 (2010) · low 0 (2019)2026

Most influential descendants

Showing 5 of 25 · See all
  • K131929Surveyor Central StationMortara Instrument, Inc. · 2013 · cites it directly6descendants
  • K093339Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · cites it directly6descendants
  • K142105Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · cites it directly4descendants
  • K173830MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · 2 generations on3descendants
  • K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K933143Model Eli 300 ElectrocardiographMortara Instrument, Inc.1994—
−1K062677Eli 350 ElectrocardiographMortara Instrument, Inc.2006—
0 (this device)K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc.2008—
+1K131929Surveyor Central StationMortara Instrument, Inc.2013—
+1K093339Eli PC ElectrocardiographMortara Instrument, Inc.20101
+1K142105Eli 380 ElectrocardiographMortara Instrument, Inc.20143
+2K173830MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.20184
+2K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201030
201120
201220
201310
201430
201510
201620
201720
201820
202010
202110
202220
202620
FIG. 1 — Lineage of K082946, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K062677Eli 350 Electrocardiograph
Summary page 1
…graph is the next generation of the Mortara ELI 350 and is substantially equivalent to the legally marketed predicate device: · ELI 350 by Mortara Instrument (K062677) The proposed ELI 350 is a modification of the Mortara predicate device. Itwill combine enhanced capabilities with the current te…
Mortara Instrument, Inc.2006—

What descends from it? (25)

See all 25

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131929Surveyor Central StationMortara Instrument, Inc.20136
K093339Eli PC ElectrocardiographMortara Instrument, Inc.20106
K142105Eli 380 ElectrocardiographMortara Instrument, Inc.20144
K101403Eli 250 ElectrocardiographMortara Instrument, Inc.20102
K102206Eli 10 Electrocardiograph Model Eli 10Mortara Instrument, Inc.20110
K101115Eli 150 Electrocardiograph Model Eli 150Mortara Instrument, Inc.20100
K092663Eli 350 ElectrocardiographMortara Instrument, Inc.20090

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?

  • The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 12.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K131929 (Mortara Instrument, Inc., 2013) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

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 (121 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.

Indications for use as stated in the FDA summary.

More from Mortara Instrument, Inc.

51 FDA decisions under this applicant name. See the company

  • K182297Surveyor S2Mortara Instrument, Inc. · 2019
  • K173765Surveyor Patient MonitorMortara Instrument, Inc. · 20182 recalls
  • K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
  • K161465CardioConfirmMortara Instrument, Inc. · 2016
  • K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. · 20161 recall

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https://510kreport.com/device/K082946 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082946: Mortara Eli 350 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082946

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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