510(k) · Cleared
ClearedHRVWatch-Mini Wrist Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Scientific Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 7, 2021 as substantially equivalent to K123130 (Taiwan Scientific Corporation, 2013) and 2 other predicates after a 333-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 7, 2021
- Review
- 333 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K963725 (1997). 40 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 2 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 1 generation backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- This deviceK201914 HRVWatch-Mini Wrist MonitorTaiwan Scientific Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −1 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| 0 (this device) | K201914 | HRVWatch-Mini Wrist Monitor | Taiwan Scientific Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K123130 | Answatch Wrist Monitor Model TS-0411Summary page 4…mmon Name: Non-invasive blood pressure meter system Classification Name: Noninvasive blood pressure measurement system 5.4 Predicate Devices: (1) HRVWatch Wrist Monitor K123130 (primary predicate device) (2) Full Automatic (NIBP) Blood Pressure Monitor HL158UA K162338 (3) Alivecor Heart Monitor K142743 5… | 2013 |
| * | K162338 | Full Automatic (NIBP) Blood Pressure MonitorSummary page 4…ressure measurement system 5.4 Predicate Devices: (1) HRVWatch Wrist Monitor K123130 (primary predicate device) (2) Full Automatic (NIBP) Blood Pressure Monitor HL158UA K162338 (3) Alivecor Heart Monitor K142743 5.5 Device Description: The non-invasive blood pressure measuring system HRVWatch-Mini Wrist… | 2016 |
| * | K142743 | AliveCor Heart MonitorSummary page 4…dicate Devices: (1) HRVWatch Wrist Monitor K123130 (primary predicate device) (2) Full Automatic (NIBP) Blood Pressure Monitor HL158UA K162338 (3) Alivecor Heart Monitor K142743 5.5 Device Description: The non-invasive blood pressure measuring system HRVWatch-Mini Wrist Monitor is a smaller size variation… | 2015 |
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 24 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 40 ancestors have a recall of any class.
- 1 other device also cites its predicate K123130.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
Indications for Use: Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at office or patients at home. The device is not intended for ambulatory use. The device has not been tested and it is not intended for pediatric use. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201914: HRVWatch-Mini Wrist Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201914
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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