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 Feb 13, 2015 as substantially equivalent to K091513 (Edan Instruments, Inc., 2009) and 1 other predicate after a 211-day review. Its family tree reaches back 5 generations to 1984. 3 later devices descend from it.
- Decided
- Feb 13, 2015
- Review
- 211 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K842308 (1984). 25 ancestors in all, the oldest K820885 (1982). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 4 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 3 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 2 generations backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- 1 generation backK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- This deviceK141946 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK160092 Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK233266 Mediblu Ecg SystemMediblu Medical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK171517 Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd. · 2016 · cites it directly1descendant
- K233266Mediblu Ecg SystemMediblu Medical, LLC · 2024 · 2 generations on0descendants
- K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −4 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −2 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −1 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| 0 (this device) | K141946 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015 | — |
| +1 | K160092 | Digital Electrocardiograph | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016 | — |
| +2 | K233266 | Mediblu Ecg System | Mediblu Medical, LLC | 2024 | — |
| +1 | K171517 | Digital Electrocardiograph | Biocare Bio-Medical Equipment Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 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? (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 |
|---|---|---|---|
| * | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Summary page 5…he ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. 5. Predicate Device Identification 510(k) Number: K091513 Product Name: Smart ECG (SE) Series Electrocardiograph, SE-12 Model: SE-12 Manufacturer: Edan Instruments, Inc… | 2009 |
| * | K050858 | Ascentia Heartstation Ecg Management SystemSummary page 5…10(k) Number: K091513 Product Name: Smart ECG (SE) Series Electrocardiograph, SE-12 Model: SE-12 Manufacturer: Edan Instruments, Inc 510(k) Number: K050858 Product Name: Ascentia HeartStationTM ECG Management System Manufacturer: Heartlab, Inc. 6. Device Description… | 2005 |
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 31 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K160092 (Shenzhen Biocare Bio-Medical Equipment Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K091513.
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?
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface
ECG c¢lectrodes. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141946: 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/K141946
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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