510(k) · Cleared
ClearedPaceart Home Trak Plus Easi Event Recorder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paceart, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jan 26, 1999 as substantially equivalent to K923930 (Tz Medical, Inc., 1992) and 3 other predicates after a 225-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Jan 26, 1999
- Review
- 225 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K930806 (1994). 5 ancestors in all, the oldest K872781 (1987). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 1 generation backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- This deviceK982090 Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK020213 Netlink/NetscanRozinn Electronics, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK193177 CER-SCardiocalm · 2020
- Descendant · 4 generations on · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
- Descendant · cites it directly · 0 of its ownK250258 HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020213Netlink/NetscanRozinn Electronics, Inc. · 2002 · cites it directly4descendants
- K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004 · 2 generations on3descendants
- K193177CER-SCardiocalm · 2020 · 3 generations on2descendants
- K213861CER-SCardiocalm Srl · 2022 · 4 generations on1descendant
- K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −1 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| 0 (this device) | K982090 | Paceart Home Trak Plus Easi Event Recorder System | Paceart, Inc. | 1999 | — |
| +1 | K020213 | Netlink/Netscan | Rozinn Electronics, Inc. | 2002 | — |
| +2 | K042002 | Synescope, Easyscope, Synecom, Holterreader | Ela Medical, Inc. | 2004 | — |
| +3 | K193177 | CER-S | Cardiocalm | 2020 | — |
| +4 | K213861 | CER-S | Cardiocalm Srl | 2022 | — |
| +1 | K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923930 | Electrocardiograph TransmitterSummary page 1…d Receiving System ' Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH) (3) Equivalent legally-marketed devices: 1. Braemar ER370, K923930 2. Paceart CPTS 86/12, K915632 3. Zymed 2010 Holter Analyzer, K955015 (analyzer only), K872781 (with EASI) 4. Totemite EASI sys… | 1992 |
| * | K915632 | Paceart CPTS-86/12Summary page 1…tion Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH) (3) Equivalent legally-marketed devices: 1. Braemar ER370, K923930 2. Paceart CPTS 86/12, K915632 3. Zymed 2010 Holter Analyzer, K955015 (analyzer only), K872781 (with EASI) 4. Totemite EASI system, K872781 (4) Description T… | 1992 |
| * | K955015 | Zymed Holter Scanner Model 2010Summary page 1…lectrocardiograph, Telephone (74DXH) (3) Equivalent legally-marketed devices: 1. Braemar ER370, K923930 2. Paceart CPTS 86/12, K915632 3. Zymed 2010 Holter Analyzer, K955015 (analyzer only), K872781 (with EASI) 4. Totemite EASI system, K872781 (4) Description The HomeTrak Plus Cardiac Twelve-Lead Eve… | 1996 |
| * | K872781 | Easi Lead System Cable AssemblySummary page 1…one (74DXH) (3) Equivalent legally-marketed devices: 1. Braemar ER370, K923930 2. Paceart CPTS 86/12, K915632 3. Zymed 2010 Holter Analyzer, K955015 (analyzer only), K872781 (with EASI) 4. Totemite EASI system, K872781 (4) Description The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-… | 1987 |
What descends from it? (6)
2 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 5 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K020213 (Rozinn Electronics, Inc., 2002) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K923930.
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 HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated
ambulatory cardiac event monitor and associated central-station receiving equipment
which are to be used for recording infrequent and elusive heart arrhythmias and
transmitting them by telephone at a later time to a central analysis center. It records three
electrocardiographic leads and derives 12 electrocardiographic leads from the three
transmitted, called the “EASI” system.
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/K982090 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982090: Paceart Home Trak Plus Easi Event Recorder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982090
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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