# K981702: Automatic Digital Electronic Wrist Blood Pressure Monitor Model Number WS-300

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Mar 5, 1999 after 295 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: 1 generation back to K952494 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952494: Digital Electronic Wrist Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. (1995) Summary page 1.

## Indications for use
The WS-300 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management.

Source page: https://510kreport.com/device/K981702
Methodology: https://510kreport.com/methodology