510(k) · Cleared
ClearedPC Ecg, Model SE-1010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DPS Electrocardiograph
Cleared on Oct 22, 2009 as substantially equivalent to K031561 (Ge Medical Systems Information Technologies, 2003) after a 108-day review. Its family tree reaches back 5 generations to 1991. 18 later devices descend from it.
- Decided
- Oct 22, 2009
- Review
- 108 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K903644 (1991). 8 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK903644 Series 1500 12-Lead Analysis OptionMarquette Electronics, Inc. · 1991
- 4 generations backK973403 Cardiosmart STMarquette Medical Systems, Inc. · 1998
- 3 generations backK991014 Case 8000 Exercise Testing SystemGeneral Electric Medical Systems Information Techn · 1999
- 2 generations backK023380 T-Wave Altermans (Twa) Algorithm OptionGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK031561 Cardiosoft/Case Cardiac Testing SystemGe Medical Systems Information Technologies · 2003
- This deviceK092010 PC Ecg, Model SE-1010Edan Instruments, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK102854 PC ECGEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 12 of its ownK131819 PC ECGEdan Instruments, Inc. · 2013
- Descendant · 3 generations on · 11 of its ownK152427 PC ECGEdan Instruments, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK131503 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K102854PC ECGEdan Instruments, Inc. · 2010 · cites it directly13descendants
- K131819PC ECGEdan Instruments, Inc. · 2013 · 2 generations on12descendants
- K152427PC ECGEdan Instruments, Inc. · 2016 · 3 generations on11descendants
- K093869SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010 · cites it directly10descendants
- K131503SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903644 | Series 1500 12-Lead Analysis Option | Marquette Electronics, Inc. | 1991 | — |
| −4 | K973403 | Cardiosmart ST | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K991014 | Case 8000 Exercise Testing System | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K023380 | T-Wave Altermans (Twa) Algorithm Option | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K031561 | Cardiosoft/Case Cardiac Testing System | Ge Medical Systems Information Technologies | 2003 | — |
| 0 (this device) | K092010 | PC Ecg, Model SE-1010 | Edan Instruments, Inc. | 2009 | — |
| +1 | K102854 | PC ECG | Edan Instruments, Inc. | 2010 | — |
| +2 | K131819 | PC ECG | Edan Instruments, Inc. | 2013 | — |
| +3 | K152427 | PC ECG | Edan Instruments, Inc. | 2016 | — |
| +1 | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +1 | K131503 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K031561 | Cardiosoft/Case Cardiac Testing SystemSummary page 1…ification Name: 21 CFR 870.2340 Electrocardiograph Product code: DPS Predicate Devices: Cardiosoft/case cardiac testing system K031561 Manufacturer: GE medical.systems information technologies Device Description: PC ECG inclu… | 2003 |
What descends from it? (18)
See all 185 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)
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 18 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K102854 (Edan Instruments, Inc., 2010) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K031561.
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?
SE-I010 PC ECG is intended to acquire ECG signals, from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-I010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092010: PC Ecg, Model SE-1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092010
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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