510(k) · Cleared
ClearedQT Ecg (QTERD100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QT Medical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Dec 6, 2023 as substantially equivalent to K220795 (QT Medical, Inc., 2022) after a 35-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Dec 6, 2023
- Review
- 35 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963725 (1997). 15 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 6 generations backK040942 VST3Biowatch Medical, Inc. · 2004
- 5 generations backK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- 4 generations backK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- 3 generations backK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- 2 generations backK180157 QT ECGQT Medical, Inc. · 2018
- 1 generation backK220795 QT ECGQT Medical, Inc. · 2022
- This deviceK233521 QT Ecg (QTERD100)QT Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −6 | K040942 | VST3 | Biowatch Medical, Inc. | 2004 | — |
| −5 | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| −4 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| −3 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| −2 | K180157 | QT ECG | QT Medical, Inc. | 2018 | — |
| −1 | K220795 | QT ECG | QT Medical, Inc. | 2022 | — |
| 0 (this device) | K233521 | QT Ecg (QTERD100) | QT Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K220795 | QT ECGSummary page 4…Classification Product Code: DXH 12.4.4. Regulation number: 870.2920 12.4.5. Device Class: II 12.4.6. 510(k) Number: K220795 12.5. Indication for Use of the Device 12.5.1. Indication for Use: The QT ECG System is intended to acquire, record… | 2022 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
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. 2023, 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?
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities)…
Read the full statement (113 words)
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
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/K233521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233521: QT Ecg (QTERD100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233521
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