510(k) · Cleared
ClearedBiolog 3000 Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical, Inc. · DPS Electrocardiograph
Cleared on Apr 1, 1998 after a 133-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 1, 1998
- Review
- 133 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK974351 Biolog 3000 ElectrocardiographMicromedical, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK030535 Ekgcard SystemQrs Diagnostic, LLC · 2003
- Descendant · 2 generations on · 2 of its ownK050674 Physioglove ESCommwell, Ltd. · 2006
- Descendant · 3 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K030535Ekgcard SystemQrs Diagnostic, LLC · 2003 · cites it directly5descendants
- K050674Physioglove ESCommwell, Ltd. · 2006 · 2 generations on2descendants
- K103791Physioglove ES with Ecg AnalysisCommwell, Ltd. · 2011 · 3 generations on1descendant
- K103427Mobileecg SystemMemtec Corp. · 2011 · cites it directly1descendant
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974351 | Biolog 3000 Electrocardiograph | Micromedical, Inc. | 1998 | — |
| +1 | K030535 | Ekgcard System | Qrs Diagnostic, LLC | 2003 | — |
| +2 | K050674 | Physioglove ES | Commwell, Ltd. | 2006 | — |
| +3 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | MAX 1 Exercise Testing System Named without a submission number |
What descends from it? (6)
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?
- Of its descendants, K030535 (Qrs Diagnostic, LLC, 2003) has gone furthest, with 5 descendants of its own.
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?
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms…
Read the full statement (122 words)
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000 unit, a User’s Manual, and accessories. Additional device description information is presented in = i iption.
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/K974351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974351: Biolog 3000 Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974351
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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