510(k) · Cleared
ClearedSensor Mobile SM 100 Vitaphone 1001R Remos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tms Telemedizinische Systeme GmbH · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Mar 30, 2005 as substantially equivalent to K963904 (Heart Alert, Inc., 1997) after a 15-day review. Its family tree reaches back 1 generation to 1997. 5 later devices descend from it.
- Decided
- Mar 30, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963904 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963904 P.H.D. - Personal Heart Device Model 5258Heart Alert, Inc. · 1997
- This deviceK050670 Sensor Mobile SM 100 Vitaphone 1001R RemosTms Telemedizinische Systeme GmbH · 2005
- Descendant · cites it directly · 2 of its ownK053378 Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006
- Descendant · 2 generations on · 1 of its ownK100383 Vitaphone. Model 100 BTVitasystems GmbH · 2010
- Descendant · cites it directly · 1 of its ownK082013 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008
- Descendant · 3 generations on · 0 of its ownK151013 Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK083630 Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2009
Most influential descendants
Showing 5 of 5 · See all- K053378Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006 · cites it directly2descendants
- K100383Vitaphone. Model 100 BTVitasystems GmbH · 2010 · 2 generations on1descendant
- K082013Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2008 · cites it directly1descendant
- K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015 · 3 generations on0descendants
- K083630Clue Medical and Clue Medical BasicTelovital GmbH Telemedizin · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963904 | P.H.D. - Personal Heart Device Model 5258 | Heart Alert, Inc. | 1997 | — |
| 0 (this device) | K050670 | Sensor Mobile SM 100 Vitaphone 1001R Remos | Tms Telemedizinische Systeme GmbH | 2005 | — |
| +1 | K053378 | Loop Recorder Vitaphone, 3100 Series | Tms Telemedizinische Systeme GmbH | 2006 | — |
| +2 | K100383 | Vitaphone. Model 100 BT | Vitasystems GmbH | 2010 | — |
| +1 | K082013 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2008 | — |
| +3 | K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | 2015 | — |
| +2 | K083630 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K963904 | P.H.D. - Personal Heart Device Model 5258Summary page 2…Device Predicate Device: Manufacturer: Predicate 510(K): PHD T M Heart Alert, Inc. K963904 6. Applicable Standards - IEC 60601-1:1988, "Medical Electrical Equipment, General Requirements for Safety" - IEC 60601-1… | 1997 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K053378 (Tms Telemedizinische Systeme GmbH, 2006) 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 | — |
What is it indicated for?
Symptomatic disturbances of cardiac rhythm such as palpitations, fatigue, heart racing,
fluttering, chest discomfort or pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050670: Sensor Mobile SM 100 Vitaphone 1001R Remos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050670
Report an extraction error
Are you the manufacturer?
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