# K201914: HRVWatch-Mini Wrist Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Scientific Corporation
- Decided: Jun 7, 2021 after 333 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123130: Answatch Wrist Monitor Model TS-0411, Taiwan Scientific Corporation (2013) Summary page 4.
- K162338: Full Automatic (NIBP) Blood Pressure Monitor, Health & Life Co., Ltd. (2016) Summary page 4.
- K142743: AliveCor Heart Monitor, AliveCor, Inc. (2015) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K201914
Methodology: https://510kreport.com/methodology