510(k) · Cleared
ClearedCardiodirect, Models 12M, 12I, 12S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DPS Electrocardiograph
Cleared on Aug 1, 2003 as substantially equivalent to K013367 (Reynolds Medical, Ltd., 2001) and 3 other predicates after a 221-day review. Its family tree reaches back 4 generations to 1993. 4 later devices descend from it.
- Decided
- Aug 1, 2003
- Review
- 221 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K921669 (1993). 13 ancestors in all, the oldest K820885 (1982). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 3 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 2 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 1 generation backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- This deviceK024283 Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK093211 Carecenter MDCardiac Science Corporation · 2010
- Descendant · 2 generations on · 0 of its ownK123217 CardeascreenCardea Associates, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK082380 Vicardio 12BEnergy-Lab Technologies GmbH · 2008
- Descendant · cites it directly · 0 of its ownK062469 Voyager 12Del Mar Reynolds Medical, Ltd. · 2006
Most influential descendants
Showing 4 of 4 · See all- K093211Carecenter MDCardiac Science Corporation · 2010 · cites it directly1descendant
- K123217CardeascreenCardea Associates, Inc. · 2013 · 2 generations on0descendants
- K082380Vicardio 12BEnergy-Lab Technologies GmbH · 2008 · cites it directly0descendants
- K062469Voyager 12Del Mar Reynolds Medical, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −3 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −2 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −1 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| 0 (this device) | K024283 | Cardiodirect, Models 12M, 12I, 12S | Reynolds Medical, Ltd. | 2003 | — |
| +1 | K093211 | Carecenter MD | Cardiac Science Corporation | 2010 | — |
| +2 | K123217 | Cardeascreen | Cardea Associates, Inc. | 2013 | — |
| +1 | K082380 | Vicardio 12B | Energy-Lab Technologies GmbH | 2008 | — |
| +1 | K062469 | Voyager 12 | Del Mar Reynolds Medical, Ltd. | 2006 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (4)
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.
What descends from it? (4)
3 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 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K093211 (Cardiac Science Corporation, 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K013367.
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 use of CardioDirect is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram, a rhythm electrocardiogram, or a stress electrocardiogram (such as might be taken during an exercise stress test).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024283: Cardiodirect, Models 12M, 12I, 12S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024283
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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