510(k) · Cleared
ClearedSE-601 Series Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DPS Electrocardiograph
Cleared on Apr 1, 2010 as substantially equivalent to K092010 (Edan Instruments, Inc., 2009) and 1 other predicate after a 105-day review. Its family tree reaches back 6 generations to 1991. 10 later devices descend from it.
- Decided
- Apr 1, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K903644 (1991). 13 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 5 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 4 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 3 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 2 generations backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- 1 generation backK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- This deviceK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK131503 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK170995 ElectrocardiographEdan Instruments, Inc. · 2017
- Descendant · 4 generations on · 2 of its ownK212278 ElectrocardiographEdan Instruments, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K131503SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014 · cites it directly9descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 2 generations on8descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 3 generations on3descendants
- K170995ElectrocardiographEdan Instruments, Inc. · 2017 · 3 generations on3descendants
- K212278ElectrocardiographEdan Instruments, Inc. · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −5 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −4 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −3 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −2 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| −1 | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| 0 (this device) | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +1 | K131503 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2014 | — |
| +2 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +3 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
| +3 | K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017 | — |
| +4 | K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092010 | PC Ecg, Model SE-1010Summary page 1…h information: Class II Product code: DPS Review Panel: Cardiovascular Predicate Devices: PC EGG cleared under K092010 Manufacturer: Edan Instruments, Inc. SE-601 series Electrocardiograph c… | 2009 |
| * | K090367 | SE-601 Series ElectrocardiographSummary page 1…C EGG cleared under K092010 Manufacturer: Edan Instruments, Inc. SE-601 series Electrocardiograph cleared under K090367 Manufacturer: Edan Instruments, Inc. Device Description: SE-601 series Smart EGG includes t… | 2009 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131503 | SE-601 Series Electrocardiograph | 2014 | 9 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K131503 (Edan Instruments, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K092010.
How does its category compare?
All DPS devicesDPS 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
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 intended use of SE-601 is 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 as stated in the FDA summary.
https://510kreport.com/device/K093869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093869: SE-601 Series Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093869
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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