510(k) · Cleared
ClearedTM2000, Model 1
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 Feb 1, 2002 as substantially equivalent to K992164 (Card Guard Scientific Survival, Ltd., 1999) after a 70-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Feb 1, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992164 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK992164 Telemedicine 2000Card Guard Scientific Survival, Ltd. · 1999
- This deviceK013879 TM2000, Model 1Card Guard Scientific Survival, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK021574 TM2000 Fetaltrace Transtelephonic Receiving CenterCard Guard Scientific Survival, Ltd. · 2002
Most influential descendants
Showing 1 of 1 · See all- K021574TM2000 Fetaltrace Transtelephonic Receiving CenterCard Guard Scientific Survival, Ltd. · 2002 · cites it directly0descendants
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) | K013879 | TM2000, Model 1 | Card Guard Scientific Survival, Ltd. | 2002 | — |
| +1 | K021574 | TM2000 Fetaltrace Transtelephonic Receiving Center | Card Guard Scientific Survival, Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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…functions. 6. Substantial Equivalence Card Guard hereby claims that the TM2000 is substantially equivalent to Telemedicine 2000, the Transtelephonic Receiving Center, K992164 The proof of substantial equivalence in all that concerns the intended use, principles of operation, features and technological… | 1999 |
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 |
|---|---|---|---|
| K021574 | TM2000 Fetaltrace Transtelephonic Receiving Center | 2002 | 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?
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 TM2000 Telemedicine Receiving Center is intended for supporting transtelephonic monitoring of Electrocardiography (ECG), Spirometric and Fetal/Maternal parameters of patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013879: TM2000, Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013879
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026