510(k) · Cleared
ClearedLoop Recorder Vitaphone, 3100 Series
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 Feb 23, 2006 as substantially equivalent to K042469 (Braemar, Inc., 2004) and 3 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 23, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K963725 (1997). 11 ancestors in all, the oldest K920984 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- This deviceK053378 Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006
- Descendant · cites it directly · 1 of its ownK100383 Vitaphone. Model 100 BTVitasystems GmbH · 2010
- Descendant · 2 generations on · 0 of its ownK151013 Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K053378 | Loop Recorder Vitaphone, 3100 Series | Tms Telemedizinische Systeme GmbH | 2006 | — |
| +1 | K100383 | Vitaphone. Model 100 BT | Vitasystems GmbH | 2010 | — |
| +2 | K151013 | Vitaphone Tele ECG Loop Recorder | Vitasystems GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042469 | Braemar ER800 Series Enhanced Algorithm Event RecorderSummary page 1…. medizinische Systeme GmbH 510(K) Number 'K042469 K020825 K050670 K042254 The subject device shares operating characteristics and features with the… | 2004 |
| * | K020825 | King of Hearts Express + AF MonitorSummary page 1…medizinische Systeme GmbH 510(K) Number 'K042469 K020825 K050670 K042254 The subject device shares operating characteristics and features with the predicate devices. Th… | 2002 |
| * | K050670 | Sensor Mobile SM 100 Vitaphone 1001R RemosSummary page 1…medizinische Systeme GmbH 510(K) Number 'K042469 K020825 K050670 K042254 The subject device shares operating characteristics and features with the predicate devices. The technical speci… | 2005 |
| * | K042254 | PMP4 Selfcheck EcgSummary page 1…medizinische Systeme GmbH 510(K) Number 'K042469 K020825 K050670 K042254 The subject device shares operating characteristics and features with the predicate devices. The technical specification compar… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100383 | Vitaphone. Model 100 BT | 2010 | 1 |
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 9 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K100383 (Vitasystems GmbH, 2010) has gone furthest, with 1 descendant 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?
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:
- Dizziness
- Heart race
- Palpitations
- Syncopes of unknown cause
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053378: Loop Recorder Vitaphone, 3100 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053378
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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