510(k) · Cleared
ClearedVST3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowatch Medical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 15, 2004 as substantially equivalent to K012223 (Card Guard Scientific Survival, Ltd., 2001) after a 156-day review. Its family tree reaches back 2 generations to 1997. 18 later devices descend from it.
- Decided
- Sep 15, 2004
- Review
- 156 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963725 (1997). 3 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 1 generation backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- This deviceK040942 VST3Biowatch Medical, Inc. · 2004
- Descendant · cites it directly · 17 of its ownK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- Descendant · 2 generations on · 11 of its ownK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- Descendant · 3 generations on · 10 of its ownK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- Descendant · 4 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 5 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007 · cites it directly17descendants
- K080047Cardiosen'cShl Telemedicine International, Ltd. · 2008 · 2 generations on11descendants
- K113514SmartheartShl Telemedicine International, Ltd. · 2012 · 3 generations on10descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 4 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −1 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| 0 (this device) | K040942 | VST3 | Biowatch Medical, Inc. | 2004 | — |
| +1 | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| +2 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| +3 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| +4 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +5 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K012223 | CG-2211 Selfcheck Ecg TransmitterSummary page 1…VST 3 is substantially equivalent to the following cleared predicate devices: K012223 Device Description The VST 3 is an ambulatory ECG monitor. It is a wearable device… | 2001 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | 2007 | 17 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063609 (Shl Telemedicine International, Ltd., 2007) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K012223.
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 Biowatch Medical VST3 is indicated for use to monitor adults with abnormal heart rhythms and other symptoms of cardiac disease, such as:
* Arrhythmia or dysrhythmia
* Skipped beats or pauses
* Rapid, slow, or irregular heart rate
* Lightheadedness or faintness
* Palpitations
The VST3 records and transmits ECG data to a remote central receiving station for interpretation by certified critical care specialists and/or a licensed over-read physician to identify cardiac rhythm disorders. The device is not intended to sound any alarms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040942: VST3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040942
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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