510(k) · Cleared
ClearedEkgcard System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qrs Diagnostic, LLC · DPS Electrocardiograph
Cleared on Jun 11, 2003 as substantially equivalent to K974351 (Micromedical, Inc., 1998) and 1 other predicate after a 111-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Jun 11, 2003
- Review
- 111 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974351 (1998). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974351 Biolog 3000 ElectrocardiographMicromedical, Inc. · 1998
- This deviceK030535 Ekgcard SystemQrs Diagnostic, LLC · 2003
- Descendant · cites it directly · 2 of its ownK050674 Physioglove ESCommwell, Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK103791 Physioglove ES with Ecg AnalysisCommwell, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK103427 Mobileecg SystemMemtec Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK133703 Physioglove ET SystemCommwell R&D, Ltd. · 2014
Most influential descendants
Showing 5 of 5 · See all- K050674Physioglove ESCommwell, Ltd. · 2006 · cites it directly2descendants
- K103791Physioglove ES with Ecg AnalysisCommwell, Ltd. · 2011 · 2 generations on1descendant
- K103427Mobileecg SystemMemtec Corp. · 2011 · cites it directly1descendant
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 2 generations on0descendants
- K133703Physioglove ET SystemCommwell R&D, Ltd. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974351 | Biolog 3000 Electrocardiograph | Micromedical, Inc. | 1998 | — |
| 0 (this device) | K030535 | Ekgcard System | Qrs Diagnostic, LLC | 2003 | — |
| +1 | K050674 | Physioglove ES | Commwell, Ltd. | 2006 | — |
| +2 | K103791 | Physioglove ES with Ecg Analysis | Commwell, Ltd. | 2011 | — |
| +1 | K103427 | Mobileecg System | Memtec Corp. | 2011 | — |
| +2 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
| +3 | K133703 | Physioglove ET System | Commwell R&D, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K974351 | Biolog 3000 ElectrocardiographSummary page 2…C. Identification of Legally Marketed Devices 1. Name: Biolog 3000 and ECG Interface 2. K Number: K97435 1 and K974220 3. Date Cleared: April 1,1998 and August 25,1998 D. Description of the Device The EKGCa… | 1998 |
| * | K974220 | Micromedical 12 Lead Simultaneous CableSummary page 2…=== C. Identification of Legally Marketed Devices 1. Name: Biolog 3000 and ECG Interface 2. K Number: K97435 1 and K974220 3. Date Cleared: April 1,1998 and August 25,1998 D. Description of the Device The EKGCardTMSystem i… | 1998 |
What descends from it? (5)
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?
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Diagnostic ECG for 12 Channel Resting ECG
- Patient Population: Male/Female/Pcdiatric to Adult
- Environment of Use: Hospital, Clinic, and Home Use
- Prescription Device by a Physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030535: Ekgcard System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030535
Report an extraction error
Are you the manufacturer?
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