510(k) · Cleared
ClearedTM2005 Personal Medical Phone Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jan 15, 2003 as substantially equivalent to K992164 (Card Guard Scientific Survival, Ltd., 1999) after a 15-day review. Its family tree reaches back 1 generation to 1999. 19 later devices descend from it.
- Decided
- Jan 15, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992164 (1999). 19 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992164 Telemedicine 2000Card Guard Scientific Survival, Ltd. · 1999
- This deviceK024365 TM2005 Personal Medical Phone CenterCard Guard Scientific Survival, Ltd. · 2003
- Descendant · cites it directly · 18 of its ownK050940 PMP4 Medical Web CenterCard Guard Scientific Survival, Ltd. · 2005
- Descendant · 2 generations on · 16 of its ownK131699 Emotion Ecg MobileMega Electronics, Ltd. · 2013
- Descendant · 3 generations on · 8 of its ownK141813 Rhythmstar SystemRhythMedix, LLC · 2014
- Descendant · 3 generations on · 6 of its ownK143032 eMotion Faros ECG MobileMega Electronics, Ltd. · 2015
- Descendant · 4 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K050940PMP4 Medical Web CenterCard Guard Scientific Survival, Ltd. · 2005 · cites it directly18descendants
- K131699Emotion Ecg MobileMega Electronics, Ltd. · 2013 · 2 generations on16descendants
- K141813Rhythmstar SystemRhythMedix, LLC · 2014 · 3 generations on8descendants
- K143032eMotion Faros ECG MobileMega Electronics, Ltd. · 2015 · 3 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992164 | Telemedicine 2000 | Card Guard Scientific Survival, Ltd. | 1999 | — |
| 0 (this device) | K024365 | TM2005 Personal Medical Phone Center | Card Guard Scientific Survival, Ltd. | 2003 | — |
| +1 | K050940 | PMP4 Medical Web Center | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +2 | K131699 | Emotion Ecg Mobile | Mega Electronics, Ltd. | 2013 | — |
| +3 | K141813 | Rhythmstar System | RhythMedix, LLC | 2014 | — |
| +3 | K143032 | eMotion Faros ECG Mobile | Mega Electronics, Ltd. | 2015 | — |
| +4 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K992164 | Telemedicine 2000Summary page 2…basis of this special 5 10(k) premarket notification is Card Guard's belief that TM2005 is substantially equivalent to the predicate system: the TM2000 Receiving Center K992 164: it has the same intended use and main principles of operation. The main difference between the systems is that in the TM2000 is… | 1999 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050940 | PMP4 Medical Web Center | 2005 | 18 |
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?
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?
The Personal Medical PhoneTMCenter is intended for supporting transtelephonic
monitoring of Electrocardiography (ECG) parameters of cardiac patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024365: TM2005 Personal Medical Phone Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024365
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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