510(k) · Cleared
ClearedRiver- 1 Electrocardiograph (Ecg) Recorder and Transmitter
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 Sep 12, 2007 as substantially equivalent to K020825 (Card Guard Scientific Survival, Ltd., 2002) and 2 other predicates after a 282-day review. Its family tree reaches back 3 generations to 1997. 17 later devices descend from it.
- Decided
- Sep 12, 2007
- Review
- 282 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K963725 (1997). 9 ancestors in all, the oldest K920984 (1992). 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK040942 VST3Biowatch Medical, Inc. · 2004
- This deviceK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- Descendant · cites it directly · 11 of its ownK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- Descendant · 2 generations on · 10 of its ownK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- Descendant · 3 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 4 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK091579 Foresee HomeNotal Vision, Ltd. · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K080047Cardiosen'cShl Telemedicine International, Ltd. · 2008 · cites it directly11descendants
- K113514SmartheartShl Telemedicine International, Ltd. · 2012 · 2 generations on10descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 3 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 4 generations on5descendants
- K091579Foresee HomeNotal Vision, Ltd. · 2009 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K040942 | VST3 | Biowatch Medical, Inc. | 2004 | — |
| 0 (this device) | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| +1 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| +2 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| +3 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +4 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
| +1 | K091579 | Foresee Home | Notal Vision, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K020825 | King of Hearts Express + AF MonitorSummary page 1…ce: River-I Electrocardiograph (ECG) Recorder and Transmitter 3. Predicate Devices: King of Hearts® Express+ AF Monitor K020825 VST~h Vital Signs Recorder and Transmitter K040942 CardioCa… | 2002 |
| * | K040942 | VST3Summary page 1…ransmitter 3. Predicate Devices: King of Hearts® Express+ AF Monitor K020825 VST~h Vital Signs Recorder and Transmitter K040942 CardioCalfl' Event Recorder K972649 4. Description: The River-i is a patie… | 2004 |
| * | K972649 | Cardiocall Cardiac Event RecorderSummary page 1…+ AF Monitor K020825 VST~h Vital Signs Recorder and Transmitter K040942 CardioCalfl' Event Recorder K972649 4. Description: The River-i is a patient activated electrocardiograph (ECG) symptomatic event… | 1997 |
What descends from it? (17)
See all 172 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 10 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K080047 (Shl Telemedicine International, Ltd., 2008) has gone furthest, with 11 descendants of its own.
- 10 other devices also cite its predicate K020825.
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. 2007, 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 River-1 is indicated for the evaluation of patients who experience transient symptoms such as dizziness, palpitations, syncope, or chest pain that might suggest arrhythmia. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once the data is recorded, the patient transmits this ECG data over the telephone or cellular network to a remote central receiving station to be reviewed by a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063609
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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