510(k) · Cleared
ClearedElectrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Carewell Electronics Co., Ltd. · DPS Electrocardiograph
Cleared on Apr 25, 2012 as substantially equivalent to K101876 (Shenzhen Biocare Electronics Co., Ltd., 2011) after a 154-day review. Its family tree reaches back 6 generations to 1993. 3 later devices descend from it.
- Decided
- Apr 25, 2012
- Review
- 154 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). 3 later devices descend from it, 2 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 deviceK113485 ElectrocardiographShenzhen Carewell Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK131900 Contec ElectrocardiographContec Medical System Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK180432 AI-ECG PlatformShenzhen Carewell Electronics., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK171360 CONTEC™ ElectrocardiographContec Medical Systems Co.,Ltd · 2018
Most influential descendants
Showing 3 of 3 · See allView 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) | K113485 | Electrocardiograph | Shenzhen Carewell Electronics Co., Ltd. | 2012 | — |
| +1 | K131900 | Contec Electrocardiograph | Contec Medical System Co., Ltd. | 2014 | — |
| +1 | K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | 2018 | — |
| +2 | K171360 | CONTEC™ Electrocardiograph | Contec Medical Systems Co.,Ltd | 2018 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 2 | 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…Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. 5. Predicate Device Identification 510(k)Number:K101876 Product Name:Digital Electrocardiograph Manufacturer:Digital Electrocardiograph 6. Device Description Carewell Digi… | 2011 |
What descends from it? (3)
2 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 19 years and passes through 5 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, K131900 (Contec Medical System Co., Ltd., 2014) has gone furthest, with 1 descendant 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. 2012, 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?
Electrocardiographs, ECG-I1OIGQ), ECG-1103G(l), ECG-IlO3LW(I), ECG-1106L, ECG-1112 and ECG-11I12D, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. It could complete the ECG measurements of QRS detection, Heart Rate, ventricular ectopic beat (VEB), supraventricular ectopic beat (SVEB) and ST Segment Deviation. ECG with measurements is offered to clinician on an advisory basis only. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113485 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113485: Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113485
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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