510(k) · Cleared
ClearedPaceart Cardiovoice
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 16, 1996 after a 259-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 16, 1996
- Review
- 259 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK952065 Paceart CardiovoicePaceart, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK024278 Paceart SystemMedtronic Vascular · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK110693 Paceart Optima System SoftwareMedtronic, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK142349 TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK991211 Eventstation Ecg Trans-Telephonic Receiving SystemReynolds Medical, Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK982034 E-Fax SystemBlakbag, Ltd., Division of Coherent Systems · 1999
Most influential descendants
Showing 5 of 5 · See all- K024278Paceart SystemMedtronic Vascular · 2003 · cites it directly2descendants
- K110693Paceart Optima System SoftwareMedtronic, Inc. · 2011 · 2 generations on1descendant
- K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc. · 2015 · 3 generations on0descendants
- K991211Eventstation Ecg Trans-Telephonic Receiving SystemReynolds Medical, Ltd. · 1999 · cites it directly0descendants
- K982034E-Fax SystemBlakbag, Ltd., Division of Coherent Systems · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952065 | Paceart Cardiovoice | Paceart, Inc. | 1996 | — |
| +1 | K024278 | Paceart System | Medtronic Vascular | 2003 | 2 |
| +2 | K110693 | Paceart Optima System Software | Medtronic, Inc. | 2011 | — |
| +3 | K142349 | TM eCloud ECG Analysis System | Telemed Solutions, Inc. | 2015 | — |
| +1 | K991211 | Eventstation Ecg Trans-Telephonic Receiving System | Reynolds Medical, Ltd. | 1999 | — |
| +1 | K982034 | E-Fax System | Blakbag, Ltd., Division of Coherent Systems | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K024278 (Medtronic Vascular, 2003) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K952065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952065: Paceart Cardiovoice.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952065
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026