510(k) · Cleared
ClearedP.H.D. - Personal Heart Device Model 5258
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heart Alert, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on May 15, 1997 after a 227-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 15, 1997
- Review
- 227 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK963904 P.H.D. - Personal Heart Device Model 5258Heart Alert, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK050670 Sensor Mobile SM 100 Vitaphone 1001R RemosTms Telemedizinische Systeme GmbH · 2005
- Descendant · 2 generations on · 2 of its ownK053378 Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006
- Descendant · 3 generations on · 1 of its ownK100383 Vitaphone. Model 100 BTVitasystems GmbH · 2010
- Descendant · 2 generations on · 1 of its ownK082013 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008
- Descendant · 4 generations on · 0 of its ownK151013 Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050670Sensor Mobile SM 100 Vitaphone 1001R RemosTms Telemedizinische Systeme GmbH · 2005 · cites it directly5descendants
- K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006 · 2 generations on2descendants
- K100383Vitaphone. Model 100 BTVitasystems GmbH · 2010 · 3 generations on1descendant
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · 2 generations on1descendant
- K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963904 | P.H.D. - Personal Heart Device Model 5258 | Heart Alert, Inc. | 1997 | — |
| +1 | K050670 | Sensor Mobile SM 100 Vitaphone 1001R Remos | Tms Telemedizinische Systeme GmbH | 2005 | — |
| +2 | K053378 | Loop Recorder Vitaphone, 3100 Series | Tms Telemedizinische Systeme GmbH | 2006 | — |
| +3 | K100383 | Vitaphone. Model 100 BT | Vitasystems GmbH | 2010 | — |
| +2 | K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2008 | — |
| +4 | K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050670 | Sensor Mobile SM 100 Vitaphone 1001R Remos | 2005 | 5 |
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, K050670 (Tms Telemedizinische Systeme GmbH, 2005) has gone furthest, with 5 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/K963904 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963904: P.H.D. - Personal Heart Device Model 5258.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963904
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026