510(k) · Cleared
ClearedCardiocollect Portable Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DPS Electrocardiograph
Cleared on Dec 13, 2001 as substantially equivalent to K002459 (Agilent Technologies, Inc., 2000) after a 64-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.
- Decided
- Dec 13, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002459 (2000). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002459 Pagewriter 10/10I, Model M2662A Handheld ElectrocardiographAgilent Technologies, Inc. · 2000
- This deviceK013367 Cardiocollect Portable ElectrocardiographReynolds Medical, Ltd. · 2001
- Descendant · cites it directly · 4 of its ownK024283 Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK053083 Datrix Cardio Wifi ElectrocardiographDatrix · 2005
- Descendant · 2 generations on · 1 of its ownK103427 Mobileecg SystemMemtec Corp. · 2011
- Descendant · 2 generations on · 1 of its ownK093211 Carecenter MDCardiac Science Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K024283Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003 · cites it directly4descendants
- K053083Datrix Cardio Wifi ElectrocardiographDatrix · 2005 · cites it directly2descendants
- K103427Mobileecg SystemMemtec Corp. · 2011 · 2 generations on1descendant
- K093211Carecenter MDCardiac Science Corporation · 2010 · 2 generations on1descendant
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002459 | Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph | Agilent Technologies, Inc. | 2000 | — |
| 0 (this device) | K013367 | Cardiocollect Portable Electrocardiograph | Reynolds Medical, Ltd. | 2001 | — |
| +1 | K024283 | Cardiodirect, Models 12M, 12I, 12S | Reynolds Medical, Ltd. | 2003 | — |
| +1 | K053083 | Datrix Cardio Wifi Electrocardiograph | Datrix | 2005 | — |
| +2 | K103427 | Mobileecg System | Memtec Corp. | 2011 | — |
| +2 | K093211 | Carecenter MD | Cardiac Science Corporation | 2010 | — |
| +3 | 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 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K002459 | Pagewriter 10/10I, Model M2662A Handheld ElectrocardiographSummary page 1…mmon Name: Ambulatory electrocardiograph without analysis Classification name: Electrocardiograph (74DPS, 870.2340) Equivalent legally-marketed devices. Agilent M2662A, K002459 Description KO13367 o (2 Page A2 CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph t… | 2000 |
What descends from it? (8)
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?
- Its one ancestor has no recall.
- Of its descendants, K024283 (Reynolds Medical, Ltd., 2003) has gone furthest, with 4 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?
CardioCollect is a small, portable rechargeable-battery-powered digital electrocardiograph intended to be used by technicians to acquire 12-lead ECG’s from up to 40 patients, and then print them or store them digitally in the patient’s record in a computer (or both). The unit prints by direct connection to a printer. The unit meets all specifications for 12-lead electrocardiographs and has a provision for entry of patient data using its keypad.
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/K013367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013367: Cardiocollect Portable Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013367
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026