# K190893: Non-invasive Hemodynamic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Vita-Course Technologies Co., Ltd.
- Decided: Aug 7, 2019 after 124 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: 4 generations back to K880572 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093981: Yrnsortip Oximanometer, Cnoga Medical, Ltd. (2010) Summary page 4.

## Indications for use
The Discovery 1 - Non-invasive Hemodynamic Blood Pressure Monitor device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.

Source page: https://510kreport.com/device/K190893
Methodology: https://510kreport.com/methodology