510(k) · Cleared
ClearedHeart Access Plus Cardiac Event Recorder
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 Nov 12, 1997 as substantially equivalent to K923930 (Tz Medical, Inc., 1992) after an 83-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Nov 12, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923930 (1992). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K012407Paceart TX3 Cardiac Event RecorderPaceart, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| 0 (this device) | K973141 | Heart Access Plus Cardiac Event Recorder | Paceart, Inc. | 1997 | — |
| +1 | K012407 | Paceart TX3 Cardiac Event Recorder | Paceart, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 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? (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 |
|---|---|---|---|
| * | K923930 | Electrocardiograph TransmitterSummary page 1…trocardiograph, Telephone (74DXH) (3) Classification, Panel Class II, 74DRX (4) Predicate Devices: 1. Ralin Heart-Aide Event recorder 2. Braemar ER700 Event Recorder, K923930 (5) Description The Paceart “Heart Access Plus”™ combines a “looping” cardiac event recorder and a voice diary. The "“looping”… | 1992 |
| * | — | Ralin Heart-Aide Event recorder Named without a submission number |
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 |
|---|---|---|---|
| K012407 | Paceart TX3 Cardiac Event Recorder | 2001 | 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?
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 event recorder, called the “Heart Access Plus,” 1is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms 1indicated to him by his physician. The unit is intended to be used in the patient’s home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be…
Read the full statement (163 words)
The event recorder, called the “Heart Access Plus,” 1is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms 1indicated to him by his physician. The unit is intended to be used in the patient’s home, place of work, or when traveling. Recordings are then to be transmitted telephonically to a central receiver, where they are printed as received and then can be interpreted by a physician.
The unit also has a voice diary so that the patients can record notes of the circumstances when the event was recorded. The Heart RAccess Plus operates in the so-called “Looping” mode, in which it is always active, and in which it records an interval of one channel of cardiac activity pefore and an interval after the depression of the button; The durations of the intervals are programmable. The intended patient population 1s patients experiencing intermittent and unexpected cardiac events and arrhythmias.
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/K973141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973141: Heart Access Plus Cardiac Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973141
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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