510(k) Report

510(k) · Cleared

Cleared

Eli 350 Electrocardiograph

K062677510(k) SpecialCleared Nov 15, 200668-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 Nov 15, 2006 as substantially equivalent to K933143 (Mortara Instrument, Inc., 1994) after a 68-day review. Its family tree reaches back 1 generation to 1994. 26 later devices descend from it.

Decided
Nov 15, 2006
Review
68 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K933143 (1994). 26 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2011: 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. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 7 descendants4 generations forward: 6 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K933143 · Model Eli 300 Electrocardiograph · Mortara Instrument, Inc. · 19940+5
  1. Root · 1 generation backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
  2. This deviceK062677 Eli 350 ElectrocardiographMortara Instrument, Inc. · 2006
  3. Descendant · cites it directly · 25 of its ownK082946 Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008
  4. Descendant · 2 generations on · 6 of its ownK131929 Surveyor Central StationMortara Instrument, Inc. · 2013
  5. Descendant · 2 generations on · 6 of its ownK093339 Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 4 of its ownK142105 Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · Recalled
  7. Descendant · 3 generations on · 3 of its ownK173830 MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · Recalled

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 32011: 22012: 22013: 12014: 32015: 12016: 22017: 22018: 22020: 12021: 12022: 22026: 2
2008high 3 (2010) · low 0 (2019)2026

Most influential descendants

Showing 5 of 26 · See all
  • K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc. · 2008 · cites it directly25descendants
  • K131929Surveyor Central StationMortara Instrument, Inc. · 2013 · 2 generations on6descendants
  • K093339Eli PC ElectrocardiographMortara Instrument, Inc. · 2010 · 2 generations on6descendants
  • K142105Eli 380 ElectrocardiographMortara Instrument, Inc. · 2014 · 2 generations on4descendants
  • K173830MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc. · 2018 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933143Model Eli 300 ElectrocardiographMortara Instrument, Inc.1994—
0 (this device)K062677Eli 350 ElectrocardiographMortara Instrument, Inc.2006—
+1K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc.2008—
+2K131929Surveyor Central StationMortara Instrument, Inc.2013—
+2K093339Eli PC ElectrocardiographMortara Instrument, Inc.20101
+2K142105Eli 380 ElectrocardiographMortara Instrument, Inc.20143
+3K173830MAC VU360 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.20184

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201030
201120
201220
201310
201430
201510
201620
201720
201820
202010
202110
202220
202620
FIG. 1 — Lineage of K062677, 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
*K933143Model Eli 300 Electrocardiograph
Summary page 1
…a current technology evolution of the Mortara ELI 300 and is substantially equivalent to the legally marketed predicate device: * ELI 300 by Mortara Instrument (K933143) The proposed ELI 350 is a direct evolution of this Mortara predicate device. Itwill combine ELI 300 technologies with current te…
Mortara Instrument, Inc.1994—

Also cleared against K933143: 1 other device →

What descends from it? (26)

See all 26

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082946Mortara Eli 350 ElectrocardiographMortara Instrument, Inc.200825

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, K082946 (Mortara Instrument, Inc., 2008) has gone furthest, with 25 descendants of its own.
  • 1 other device also cites its predicate K933143.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 (136 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 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 as stated in the FDA summary.

Also cleared against K933143

1 other device cites the same predicate.

  • K962970Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997

More from Mortara Instrument, Inc.

51 FDA decisions under this applicant name. See the company

  • K182297Surveyor S2Mortara Instrument, Inc. · 2019
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  • 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/K062677 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062677: Eli 350 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062677

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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