510(k) · Cleared
ClearedTelzuit Cardiac Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telzuit Technologies, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 9, 2003 as substantially equivalent to K003707 (Cardionet, 2001) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Jul 9, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813101 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813101 | Cardiobeeper Memory Monitor | Survival Technology, Inc. | 1981 | — |
| −1 | K965101 | Cardiobeeper CB-12L | Meridian Medical Technologies, Inc. | 1997 | 1 |
| 0 (this device) | K031229 | Telzuit Cardiac Monitoring System | Telzuit Technologies, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K003707 | Cardionet Ambulatory Ecg Monitor, Model CN1000ASummary page 1…ardiograph (ECG) transmitter and receiver 3. PREDICATE DEVICES CardioNet Ambulatory ECG Monitor, CardioNet, Inc. (K003707) CardioBeeperB CB- 12L, Meridian Medical Technology (K965 101) 4. INTENDED USE The TelZuit Cardiac Monitorin… | 2001 |
| * | K965101 | Cardiobeeper CB-12LSummary page 1…. PREDICATE DEVICES CardioNet Ambulatory ECG Monitor, CardioNet, Inc. (K003707) CardioBeeperB CB- 12L, Meridian Medical Technology (K965 101) 4. INTENDED USE The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiograph) monitor… | 1997 |
| † | K841944 | Disposable Ecg Electrode | 1985 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 2 other devices also cite its predicate K003707.
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 TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via cellular telephone to a remotely located ECG analysis station for evaluation by a medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031229: Telzuit Cardiac Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031229
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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