510(k) · Cleared
ClearedSmartheart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shl Telemedicine International, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 22, 2012 as substantially equivalent to K080047 (Shl Telemedicine International, Ltd., 2008) after an 86-day review. Its family tree reaches back 5 generations to 1997. 10 later devices descend from it.
- Decided
- Feb 22, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). 12 ancestors in all, the oldest K920984 (1992). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK040942 VST3Biowatch Medical, Inc. · 2004
- 2 generations backK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- 1 generation backK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- This deviceK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 2 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK201669 SimpleSENSENanowear, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK180157 QT ECGQT Medical, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK220795 QT ECGQT Medical, Inc. · 2022
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · cites it directly6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 2 generations on5descendants
- K201669SimpleSENSENanowear, Inc. · 2020 · 3 generations on3descendants
- K180157QT ECGQT Medical, Inc. · 2018 · cites it directly2descendants
- K220795QT ECGQT Medical, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K040942 | VST3 | Biowatch Medical, Inc. | 2004 | — |
| −2 | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| −1 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| 0 (this device) | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| +1 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +2 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +3 | K201669 | SimpleSENSE | Nanowear, Inc. | 2020 | — |
| +1 | K180157 | QT ECG | QT Medical, Inc. | 2018 | — |
| +2 | K220795 | QT ECG | QT Medical, Inc. | 2022 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K080047 | Cardiosen'cSummary page 2…redicate device: Device Name 510k No Date of Clearance CardioSenC TM K080047 Jul 11, 2008 Performance Standards: The Smart/wart device has been tested according to various standards… | 2008 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K142476 (Healthwatch, Ltd., 2015) has gone furthest, with 6 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. 2012, 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 Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smart/wart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113514: Smartheart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113514
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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