510(k) · Cleared
ClearedDatrix Cardio Wifi Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix · DPS Electrocardiograph
Cleared on Nov 30, 2005 as substantially equivalent to K013367 (Reynolds Medical, Ltd., 2001) after a 28-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Nov 30, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002459 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002459 Pagewriter 10/10I, Model M2662A Handheld ElectrocardiographAgilent Technologies, Inc. · 2000
- 1 generation backK013367 Cardiocollect Portable ElectrocardiographReynolds Medical, Ltd. · 2001
- This deviceK053083 Datrix Cardio Wifi ElectrocardiographDatrix · 2005
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002459 | Pagewriter 10/10I, Model M2662A Handheld Electrocardiograph | Agilent Technologies, Inc. | 2000 | — |
| −1 | K013367 | Cardiocollect Portable Electrocardiograph | Reynolds Medical, Ltd. | 2001 | — |
| 0 (this device) | K053083 | Datrix Cardio Wifi Electrocardiograph | Datrix | 2005 | — |
| +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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K013367 | Cardiocollect Portable ElectrocardiographSummary page 1…EVICE: The legally marketed device/s to which equivalence is being claimed is the CardioCollect Portable Electrocardiograph manufactured by Reynolds Medical, Ltd. (K013367). 6. DEVICE DESCRIPTION The Cardio WiFi electrocardiograph continuously records data to a flashcard and displays it… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103427 | Mobileecg System | 2011 | 1 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103427 (Memtec Corp., 2011) 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 Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053083: Datrix Cardio Wifi Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053083
Report an extraction error
Are you the manufacturer?
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