510(k) · Cleared
Recalled · 2010Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200
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 24, 2009 as substantially equivalent to K014108 (General Electric Medical Systems Information Techn, 2002) after a 63-day review. Its family tree reaches back 4 generations to 1993. 32 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921669 (1993). 9 ancestors in all, the oldest K820885 (1982). 32 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 3 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 2 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 1 generation backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- This deviceK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009
- Descendant · cites it directly · 13 of its ownK101876 Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010…Shenzhen Biocare Electronics Co., Ltd. · 2011
- Descendant · 2 generations on · 9 of its ownK112431 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2011
- Descendant · cites it directly · 9 of its ownK102830 ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK122712 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K101876Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010Shenzhen Biocare Electronics Co., Ltd. · 2011 · cites it directly13descendants
- K112431Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2011 · 2 generations on9descendants
- K102830ElectrocardiographEdan Instruments, Inc. · 2010 · cites it directly9descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 2 generations on8descendants
- K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −3 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −2 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −1 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | — |
| +1 | K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| +2 | K112431 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| +1 | K102830 | Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +2 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +2 | K122712 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K014108 | Mac 5000 Ecg Analysis SystemSummary page 1…iograph Classification Name: 21 CFR 870.2340 Electrocardiograph DPS Class II Predicate Devices: MAC 5000 ECG Analysis System K014108 Device Description: The Smart ECG (SE) Series Electrocardiograph is designed to acquire, analyze… | 2002 |
What descends from it? (32)
See all 327 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 | 2011 | 13 |
| K102830 | Electrocardiograph | 2010 | 9 |
| K141946 | Digital Electrocardiograph | 2015 | 3 |
| K171943 | Electrocardiograph | 2017 | 1 |
| K123148 | Parace MD Ekoscope IS100 | 2013 | 0 |
| K130207 | Spacelabs Healthcare Cardioexpress | 2013 | 0 |
| K111805 | Ecg Series Electrocardiograph | 2011 | 0 |
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-0041-2012 | Vendor change control | The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. 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). There have… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K101876 (Shenzhen Biocare Electronics Co., Ltd., 2011) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K014108.
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 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 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/K091513 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091513: Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12, SE-12 Express and SE-1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091513
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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