510(k) · Cleared
ClearedQT ECG
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 Sep 26, 2022 as substantially equivalent to K180157 (QT Medical, Inc., 2018) after a 192-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Sep 26, 2022
- Review
- 192 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963725 (1997). 14 ancestors in all, the oldest K920984 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 5 generations backK040942 VST3Biowatch Medical, Inc. · 2004
- 4 generations backK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- 3 generations backK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- 2 generations backK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- 1 generation backK180157 QT ECGQT Medical, Inc. · 2018
- This deviceK220795 QT ECGQT Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK233521 QT Ecg (QTERD100)QT Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233521QT Ecg (QTERD100)QT Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −6 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −5 | K040942 | VST3 | Biowatch Medical, Inc. | 2004 | — |
| −4 | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| −3 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| −2 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| −1 | K180157 | QT ECG | QT Medical, Inc. | 2018 | — |
| 0 (this device) | K220795 | QT ECG | QT Medical, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K180157 | QT ECGSummary page 4…Classification Product Code: DXH Regulation number: 870.2920 Device Class: Ⅱ 510(k) Number: K180157 5.6 Indications for Use of the Device Indication for Use: The QT ECG System is intended to acquire, record and process an elec… | 2018 |
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 |
|---|---|---|---|
| K233521 | QT Ecg (QTERD100) | 2023 | 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?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K233521 (QT Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2022, 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), 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 as stated in the FDA summary.
https://510kreport.com/device/K220795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220795: QT ECG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220795
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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