510(k) · Cleared
ClearedE-Tac EX-1000 Electrocardiographic Event Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datrix, Inc. Dba of Jon Barron, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Aug 12, 2004 as substantially equivalent to K920984 (Instromedix, Inc., 1992) and 2 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1992. 42 later devices descend from it.
- Decided
- Aug 12, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K923930 (1992). 3 ancestors in all, the oldest K920984 (1992). 42 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- 1 generation backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
- This deviceK042022 E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 2 generations on · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- Descendant · 3 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- Descendant · 4 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- Descendant · 5 generations on · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc. · 2009 · cites it directly40descendants
- K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · 2 generations on38descendants
- K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 3 generations on30descendants
- K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 4 generations on24descendants
- K133701Nuvant MCT SystemCorventis, Inc. · 2014 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −1 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| 0 (this device) | K042022 | E-Tac EX-1000 Electrocardiographic Event Recorder | Datrix, Inc. Dba of Jon Barron, Inc. | 2004 | — |
| +1 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| +2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| +3 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| +4 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| +5 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K920984 | King of Hearts Express (E.X.) MonitorSummary page 1…r and receiver (class 2 device; 21 CFR 870.2920; product code: DXH) Predicate Devices * Instromedix King of Hearts Express 3x [K920984] * Braemar ER300 series (ER300, ER310, ER320) [K923930] · Braemar ER700 series (ER710 and ER720) [K981394] I… | 1992 |
| * | K923930 | Electrocardiograph TransmitterSummary page 1…1 CFR 870.2920; product code: DXH) Predicate Devices * Instromedix King of Hearts Express 3x [K920984] * Braemar ER300 series (ER300, ER310, ER320) [K923930] · Braemar ER700 series (ER710 and ER720) [K981394] Indications for Use The Datrix E-Tac EX- 1000 Electrocardiograph… | 1992 |
| * | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Summary page 1…Instromedix King of Hearts Express 3x [K920984] * Braemar ER300 series (ER300, ER310, ER320) [K923930] · Braemar ER700 series (ER710 and ER720) [K981394] Indications for Use The Datrix E-Tac EX- 1000 Electrocardiographic Event Recorder device is intended for long-term monitoring o… | 1998 |
What descends from it? (42)
See all 422 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 12 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090696 (Corventis, Inc., 2009) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K920984.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.
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/K042022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042022: E-Tac EX-1000 Electrocardiographic Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042022
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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