# K170666: The Wrist-Type Fully Automatic Digital Blood Pressure Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Nov 22, 2017 after 261 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 K002115 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121355: Wrist-Type Fully Automatic Digital Blood Pressure Monitor, Sejoy Electronics & Instruments Co., Ltd. (2012) Summary page 4.

## Indications for use
The Fully Automatic Blood Pressure Monitors are intended to measure the systolic and diastolic blood pressure and pulse rate of adults and adolescents age 12 through 21 years of age.

Source page: https://510kreport.com/device/K170666
Methodology: https://510kreport.com/methodology