510(k) · Cleared
ClearedDigital Ambulatory Ecg (Holter) Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Oct 15, 2003 as substantially equivalent to K982975 (Datrix, 1998) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Oct 15, 2003
- Review
- 194 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921068 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- 1 generation backK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- This deviceK031074 Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003
- Descendant · cites it directly · 0 of its ownK112601 Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation · 2011
Most influential descendants
Showing 1 of 1 · See all- K112601Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| −1 | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| 0 (this device) | K031074 | Digital Ambulatory Ecg (Holter) Recorder | Datrix | 2003 | — |
| +1 | K112601 | Intricon Datrix Sirona Event/ Holter Recorder | Intricon Datrix Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K982975 | Digital Ecg Holter Recorder, Model DR512Summary page 2…ally distributed ECG Holter recorders. The following chart compares the VX3 with its predecessor device (Datrix DR5 12 digital Holter recorder ( 5 lO(k): K982975), and another predicate device, (Braemar DXPl 000 digital Holter recorder ( 5 10(k): K993618) with pacemaker pulse… | 1998 |
| * | K993618 | DXP1000 Holter RecorderSummary page 2…sor device (Datrix DR5 12 digital Holter recorder ( 5 lO(k): K982975), and another predicate device, (Braemar DXPl 000 digital Holter recorder ( 5 10(k): K993618) with pacemaker pulse detection). Specification Datrix VX3 Datrix DR512… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112601 | Intricon Datrix Sirona Event/ Holter Recorder | 2011 | 0 |
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 11 years and passes through 1 company; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112601 (Intricon Datrix Corporation, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982975.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data as well as pacemaker pulses during the events of the patient’s daily activity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031074: Digital Ambulatory Ecg (Holter) Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031074
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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