510(k) · Cleared
ClearedVitaphone. Model 100 BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitasystems GmbH · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Apr 20, 2010 as substantially equivalent to K053378 (Tms Telemedizinische Systeme GmbH, 2006) and 1 other predicate after a 63-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.
- Decided
- Apr 20, 2010
- Review
- 63 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963725 (1997). 12 ancestors in all, the oldest K920984 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 1 generation backK053378 Loop Recorder Vitaphone, 3100 SeriesTms Telemedizinische Systeme GmbH · 2006
- This deviceK100383 Vitaphone. Model 100 BTVitasystems GmbH · 2010
- Descendant · cites it directly · 0 of its ownK151013 Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015
Most influential descendants
Showing 1 of 1 · See all- K151013Vitaphone Tele ECG Loop RecorderVitasystems GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −1 | K053378 | Loop Recorder Vitaphone, 3100 Series | Tms Telemedizinische Systeme GmbH | 2006 | — |
| 0 (this device) | K100383 | Vitaphone. Model 100 BT | Vitasystems GmbH | 2010 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K053378 | Loop Recorder Vitaphone, 3100 SeriesSummary page 1…Vita phone 3100 BT PMVP4 SelfCheck ECG Manufacturer Vitasystems GmbH Card Guard Ltd. 510(K) Number K053378 K042254 Table 5-1 2. Intended Use The Vitaphone 100 BT device is single-channel cardiac event recorder f… | 2006 |
| * | K042254 | PMP4 Selfcheck EcgSummary page 1…T PMVP4 SelfCheck ECG Manufacturer Vitasystems GmbH Card Guard Ltd. 510(K) Number K053378 K042254 Table 5-1 2. Intended Use The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG re… | 2005 |
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 |
|---|---|---|---|
| K151013 | Vitaphone Tele ECG Loop Recorder | 2015 | 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K151013 (Vitasystems GmbH, 2015) has gone furthest, with 0 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. 2010, this device’s year, is highlighted.
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 asymptomnatic 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/K100383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100383: Vitaphone. Model 100 BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100383
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