510(k) · Cleared
ClearedDigital Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS Electrocardiograph
Cleared on Dec 18, 2015 as substantially equivalent to K092010 (Edan Instruments, Inc., 2009) and 1 other predicate after a 116-day review. Its family tree reaches back 10 generations to 1993.
- Decided
- Dec 18, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K921669 (1993). 23 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 6 generations between
- 3 generations backK122712 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012
- 2 generations backK123816 Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd. · 2013
- 1 generation backK133985 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
- This deviceK152384 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
Show all 10 generations
- Root · 10 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 9 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 8 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 7 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 6 generations backK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- 5 generations backK101876 Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010…Shenzhen Biocare Electronics Co., Ltd. · 2011
- 4 generations backK112431 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2011
- 3 generations backK122712 Digital ElectrocardiographShenzhen Biocare Electronics Co., Ltd. · 2012
- 2 generations backK123816 Digital ElectrocardiographsShenzhen Biocare Electronics Co., Ltd. · 2013
- 1 generation backK133985 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
- This deviceK152384 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −9 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −8 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −7 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −6 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| −5 | K101876 | Digital Electrocardiograph, Models Ecg-1210, Ecg-1230, Ecg-3010, Ecg-6010 | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| −4 | K112431 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2011 | — |
| −3 | K122712 | Digital Electrocardiograph | Shenzhen Biocare Electronics Co., Ltd. | 2012 | — |
| −2 | K123816 | Digital Electrocardiographs | Shenzhen Biocare Electronics Co., Ltd. | 2013 | — |
| −1 | K133985 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015 | — |
| 0 (this device) | K152384 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K092010 | PC Ecg, Model SE-1010Summary page 5…tal Electrocardiograph installer and dongle installation program module. 5. Identification of Predicate Device(s) Predicate Device 1 510(k) Number: K092010 Product Name: PC ECG Manufacturer: Edan Instruments, Inc.… | 2009 |
| * | K133985 | Digital ElectrocardiographSummary page 6…Page 3 of 4 510(k) Summary Predicate device 2 510(k) Number: K133985 Product Name: Digital Electrocardiograph, ECG-2000 Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd. 6.… | 2015 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 4 other devices also cite its predicate K092010.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Electrocardiograph is 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 Electrocardiograph 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/K152384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152384: 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/K152384
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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