510(k) · Cleared
ClearedDigital Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Biocare Electronics Co., Ltd. · DPS Electrocardiograph
Cleared on Sep 22, 2011 as substantially equivalent to K101876 (Shenzhen Biocare Electronics Co., Ltd., 2011) after a 30-day review. Its family tree reaches back 6 generations to 1993. 9 later devices descend from it.
- Decided
- Sep 22, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921669 (1993). 11 ancestors in all, the oldest K820885 (1982). 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 4 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 3 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 2 generations backK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- 1 generation backK101876 Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010…Shenzhen Biocare Electronics Co., Ltd. · 2011
- This deviceK112431 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK122712 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 4 of its ownK123816 Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK133985 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK131900 Contec ElectrocardiographContec Medical System Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK132758 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122712Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012 · cites it directly8descendants
- K123816Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd. · 2013 · 2 generations on4descendants
- K133985Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015 · 3 generations on1descendant
- K131900Contec ElectrocardiographContec Medical System Co., Ltd. · 2014 · 2 generations on1descendant
- K132758Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −5 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −4 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −3 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −2 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| −1 | K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| 0 (this device) | K112431 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| +1 | K122712 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2012 | — |
| +2 | K123816 | Digital Electrocardiographs | Shenzhen Biocare Electronics Co., Ltd. | 2013 | — |
| +3 | K133985 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015 | — |
| +2 | K131900 | Contec Electrocardiograph | Contec Medical System Co., Ltd. | 2014 | — |
| +2 | K132758 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010Summary page 2…tially Equivalent (SE) to the predicate device, Digital Electrocardiograph (K101876), in respect of safety and effectiveness… | 2011 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122712 | Digital Electrocardiograph | 2012 | 8 |
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 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K122712 (Shenzhen Biocare Electronics Co., Ltd., 2012) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K101876.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
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/K112431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112431: Digital Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112431
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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