510(k) Report

510(k) · Cleared

Cleared

Electrocardiograph

K102830510(k) SpecialCleared Dec 2, 201064-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

Edan Instruments, Inc. · DPS Electrocardiograph

Cleared on Dec 2, 2010 as substantially equivalent to K014108 (General Electric Medical Systems Information Techn, 2002) and 1 other predicate after a 64-day review. Its family tree reaches back 5 generations to 1993. 9 later devices descend from it.

Decided
Dec 2, 2010
Review
64 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K921669 (1993). 10 ancestors in all, the oldest K820885 (1982). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 1 other ancestor1989: 1 other ancestor1982: 1 other ancestor1994: 1 other ancestor2017: 2 descendants cleared2018: 1 descendant cleared2022: 2 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK921669 · Marquette SL Series Transport Remote Acquisition · Marquette Electronics, Inc. · 1993K964750 · Eagle 4000 Patient Monitor · Marquette Electronics, Inc. · 1997K991735 · Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs · General Electric Medical Systems Information Techn · 1999K014108 · Mac 5000 Ecg Analysis System · General Electric Medical Systems Information Techn · 2002K091513 · Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 · Edan Instruments, Inc. · 2009 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K091513 · Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200 · Edan Instruments, Inc. · 2009 · recalledK014108 · Mac 5000 Ecg Analysis System · General Electric Medical Systems Information Techn · 2002K991735 · Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac 8 Electrocardiographs · General Electric Medical Systems Information Techn · 1999K964750 · Eagle 4000 Patient Monitor · Marquette Electronics, Inc. · 1997K921669 · Marquette SL Series Transport Remote Acquisition · Marquette Electronics, Inc. · 1993−50+5
  1. Root · 5 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
  2. 4 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
  3. 3 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
  4. 2 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
  5. 1 generation backK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
  6. This deviceK102830 ElectrocardiographEdan Instruments, Inc. · 2010
  7. Descendant · cites it directly · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
  8. Descendant · 2 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
  9. Descendant · 2 generations on · 3 of its ownK170995 ElectrocardiographEdan Instruments, Inc. · 2017
  10. Descendant · 3 generations on · 2 of its ownK212278 ElectrocardiographEdan Instruments, Inc. · 2022
  11. Descendant · 4 generations on · 1 of its ownK222902 Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 22018: 12021: 12022: 22023: 12024: 12026: 1
2017high 2 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all
  • K160876PC ECGEdan Instruments, Inc. · 2017 · cites it directly8descendants
  • K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 2 generations on3descendants
  • K170995ElectrocardiographEdan Instruments, Inc. · 2017 · 2 generations on3descendants
  • K212278ElectrocardiographEdan Instruments, Inc. · 2022 · 3 generations on2descendants
  • K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K921669Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc.1993—
−4K964750Eagle 4000 Patient MonitorMarquette Electronics, Inc.1997—
−3K991735Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac…General Electric Medical Systems Information Techn1999—
−2K014108Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn2002—
−1K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6…Edan Instruments, Inc.20091
0 (this device)K102830ElectrocardiographEdan Instruments, Inc.2010—
+1K160876PC ECGEdan Instruments, Inc.2017—
+2K171942ElectrocardiographEdan Instruments, Inc.2018—
+2K170995ElectrocardiographEdan Instruments, Inc.2017—
+3K212278ElectrocardiographEdan Instruments, Inc.2022—
+4K222902Electrocardiograph: SE-1200 Pro and SE-1201 ProEdan Instruments, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198910
199410
199810
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201810
202110
202220
202310
202410
202610
FIG. 1 — Lineage of K102830, 1993–2026Source: 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? (2)

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
*K014108Mac 5000 Ecg Analysis System
Summary page 1
…FR 870.2340 Electrocardiograph Class 11 Product code: DPS Predicate Devices: MAC 5000 ECG Analysis System K(014108 Manufacturer: GE medical systems information technologies SMART…
General Electric Medical Systems Information Techn2002—
*K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…
Our reading of the summary gave K041513, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SMART ECG SERIES ELECTROCARDIOGRAPH”.
Edan Instruments, Inc.20091

Also cleared against K014108: 5 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K160876PC ECGEdan Instruments, Inc.20178

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 17 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K160876 (Edan Instruments, Inc., 2017) has gone furthest, with 8 descendants of its own.
  • 5 other devices also cite its predicate K014108.

How does its category compare?

All DPS devices

DPS 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

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?

SE-12 series is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. SE-12 series is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. Trhe cardiogram recorded by SE-12 series can help users to analyze and diagnose heart disease. However the EGG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Indications for use as stated in the FDA summary.

Also cleared against K014108

5 other devices cite the same predicate.

  • K120188ElectrocardiographEdan Instruments, Inc. · 2012
  • K111805Ecg Series ElectrocardiographAdvanced Instrumentations, Inc. · 2011
  • K091513Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and…Edan Instruments, Inc. · 20091 recall
  • K033492Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
  • K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003

More from Edan Instruments, Inc.

94 FDA decisions under this applicant name. See the company

  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026
  • K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
  • K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)Edan Instruments, Inc. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025

Recent decisions in DPS

The DPS category page

  • K260640Kinetic Software LibraryMonebo Technologies, Inc. · 2026
  • K260005MyoVista wavECG (DG-200-B15-003)HeartSciences, Inc. · 2026
  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K102830 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102830: Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102830

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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