510(k) · Cleared
ClearedTelephone Electrocardiograph Transmitter and Receiver, TTM for Windows +
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rozinn Electronics, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 15, 2006 after an 81-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 15, 2006
- Review
- 81 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
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- #2 Held for the reportin the report
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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 |
|---|---|---|---|
| * | — | TTM For Windows + Transtelephonic cardiac monitoring station Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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 TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECG and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061780: Telephone Electrocardiograph Transmitter and Receiver, TTM for Windows +.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061780
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026