510(k) · Cleared
Recalled · 2010SE-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 Jun 3, 2009 as substantially equivalent to K072217 (Nihon Kohden America, Inc., 2007) after a 110-day review. Its family tree reaches back 2 generations to 1999. 13 later devices descend from it. It has been recalled once.
- Decided
- Jun 3, 2009
- Review
- 110 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K984504 (1999). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK984504 Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and AccessoriesNihon Kohden America, Inc. · 1999
- 1 generation backK072217 Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc. · 2007
- This deviceK090367 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK131503 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014
- Descendant · 3 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 4 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
- Descendant · 4 generations on · 3 of its ownK170995 ElectrocardiographEdan Instruments, Inc. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K093869SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010 · cites it directly10descendants
- K131503SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014 · 2 generations on9descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 3 generations on8descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 4 generations on3descendants
- K170995ElectrocardiographEdan Instruments, Inc. · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984504 | Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories | Nihon Kohden America, Inc. | 1999 | — |
| −1 | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M | Nihon Kohden America, Inc. | 2007 | — |
| 0 (this device) | K090367 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2009 | — |
| +1 | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +2 | K131503 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2014 | — |
| +3 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +4 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
| +4 | K170995 | Electrocardiograph | Edan Instruments, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MSummary page 1…Cardiovascular Predicate Devices: ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M K072217 Manufacturer: NIHON KOHDEN AMERICA, INC Device Description: SE-601 series Smar… | 2007 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2010 | Not classified | Z-0743-2012 | Employee error | CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093869 (Edan Instruments, Inc., 2010) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K072217.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with 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 only intended to be used on adult patients and is offered to clinicians on an advisory basis only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090367: SE-601 Series Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090367
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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