510(k) · Cleared
ClearedAI-ECG Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Carewell Electronics., Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Nov 19, 2018 as substantially equivalent to K113485 (Shenzhen Carewell Electronics Co., Ltd., 2012) and 1 other predicate after a 272-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Nov 19, 2018
- Review
- 272 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921669 (1993). 16 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 5 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 4 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 3 generations backK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- 2 generations backK101876 Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010…Shenzhen Biocare Electronics Co., Ltd. · 2011
- 1 generation backK113485 ElectrocardiographShenzhen Carewell Electronics Co., Ltd. · 2012
- This deviceK180432 AI-ECG PlatformShenzhen Carewell Electronics., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −6 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −5 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −4 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −3 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| −2 | K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| −1 | K113485 | Electrocardiograph | Shenzhen Carewell Electronics Co., Ltd. | 2012 | — |
| 0 (this device) | K180432 | AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K113485 | ElectrocardiographSummary page 4…de: DQK, DPS Regulation Number: 21 CFR 870.1425 Review Panel: Cardiovascular Classification: II 5.5. Predicate Devices 510(k) Number: K113485 (Secondary) Device Name: Electrocardiograph… | 2012 |
| * | K052883 | CardioserverSummary page 5…ewell Electronics Co., Ltd. AI-ECG Platform Manufacturer: Shenzhen Carewell Electronics Co., Ltd. 510(k) Number: K052883 (Primary) Device Name: Datrix CardioServer ECG Management System Manufacturer: Datrix, Inc 5.6. Indications for use:… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K113485.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and…
Read the full statement (183 words)
The AI-ECG Platform is designed to assist physicians in measuring and interpreting 12-lead resting ECG, and the interpretation by the analysis program may then be confirmed, edited, or deleted by the physician. The program is intended for use by qualified healthcare professionals in hospitals and other healthcare facilities for the assessment of common cardiac abnormalities, including arrhythmias, myocardial infarction, ventricular hypertrophy, and abnormal ST-T changes. The AI-ECG Platform interpretation results are not intended to be the sole means of diagnosis for any abnormal ECG. They are offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG.
The AI-ECG Platform is qualified for use in the general adult population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
The AI-ECG Platform is used with compatible resting ECG devices which can export ECG recordings in Carewell ECG, HL7 aECG, DICOM ECG, SCP ECG, or MFER ECG data format. The AI-ECG Platform is not to be used for: patient monitoring, on ECG signals collected using non-standard leads, ECG signals not collected using electrodes with conductive paste/gel/fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180432: AI-ECG Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180432
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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