510(k) · Cleared
ClearedBly-501 Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Industries, Ltd. · DPS Electrocardiograph
Cleared on Sep 26, 2001 after a 50-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 26, 2001
- Review
- 50 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Biolog™ 3000i electrocardiograph Named without a submission number |
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.
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™ 3000i Electrocardiograph with BLY-501 Adaptor 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™ 3000i 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…
Read the full statement (145 words)
The Biolog™ 3000i Electrocardiograph with BLY-501 Adaptor 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™ 3000i 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™ 3000i Electrocardiograph, a User’s Manual, a BLY-501 Adaptor, and accessories. It is intended for use with the Medtronic Physio Control LIFEPAK 500 defibrillator to visually display the patient’s ECG to the user of the LIFEPAK 500 defibrillator.
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/K012540 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012540: Bly-501 Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012540
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026