510(k) · Cleared
ClearedSE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DPS Electrocardiograph
Cleared on Jul 2, 2026 as substantially equivalent to K210140 (Edan Instruments, Inc., 2021) after a 330-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Jul 2, 2026
- Review
- 330 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K903644 (1991). 40 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 12 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 8 generations between
- 3 generations backK160876 PC ECGEdan Instruments, Inc. · 2017
- 2 generations backK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- 1 generation backK210140 electrocardiograph: SE-1202Edan Instruments, Inc. · 2021
- This deviceK252463 SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 11 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 10 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 9 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 8 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 7 generations backK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- 6 generations backK102854 PC ECGEdan Instruments, Inc. · 2010
- 5 generations backK131819 PC ECGEdan Instruments, Inc. · 2013
- 4 generations backK152427 PC ECGEdan Instruments, Inc. · 2016
- 3 generations backK160876 PC ECGEdan Instruments, Inc. · 2017
- 2 generations backK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- 1 generation backK210140 electrocardiograph: SE-1202Edan Instruments, Inc. · 2021
- This deviceK252463 SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −11 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −10 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −9 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −8 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −7 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| −6 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| −5 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| −4 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| −3 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| −2 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
| −1 | K210140 | electrocardiograph: SE-1202 | Edan Instruments, Inc. | 2021 | — |
| 0 (this device) | K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K210140 | electrocardiograph: SE-1202Summary page 5…DPS - Electrocardiograph 3. Predicate Device(s): Primary Predicate Device: Edan Instruments, Inc., Electrocardiograph, Model: SE-1202 (K210140) 4. Device Description: The SE-1202 Series Electrocardiograph feature an LCD touch screen, an operation… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 40 ancestors have a recall of any class.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SE-1202 Series Electrocardiograph is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252463: SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252463
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026