510(k) · Cleared
ClearedVicardio 12B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Energy-Lab Technologies GmbH · DPS Electrocardiograph
Cleared on Dec 3, 2008 as substantially equivalent to K024283 (Reynolds Medical, Ltd., 2003) and 1 other predicate after a 106-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Dec 3, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921669 (1993). 14 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 5 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 4 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 3 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 2 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK024283 Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003
- This deviceK082380 Vicardio 12BEnergy-Lab Technologies GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −4 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −3 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K024283 | Cardiodirect, Models 12M, 12I, 12S | Reynolds Medical, Ltd. | 2003 | — |
| 0 (this device) | K082380 | Vicardio 12B | Energy-Lab Technologies GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K024283 | Cardiodirect, Models 12M, 12I, 12SSummary page 1…: vicardio 12b Common Name: Electrocardiograph Classification Name: Electrocardiograph (3) Equivalent legally-marketed devices: Spacelabs CardioDirect K024283 Spacelabs CardioCollect K01 3 367 (4) Description The vicardio is a digital, PC-based electrocardiograph with a special… | 2003 |
| * | K013367 | Cardiocollect Portable ElectrocardiographSummary page 1…ectrocardiograph Classification Name: Electrocardiograph (3) Equivalent legally-marketed devices: Spacelabs CardioDirect K024283 Spacelabs CardioCollect K01 3 367 (4) Description The vicardio is a digital, PC-based electrocardiograph with a special isolation amplifier between the pa… | 2001 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K024283.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 vicardiol2b is indicated for the recording of resting electrocardiograms (ECG), and for making measurements on the electrocardiograms, by a physician or under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082380: Vicardio 12B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082380
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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