# K112690: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Feb 24, 2012 after 162 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 K000177 (2000). 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)
- K000177: Renegade HI-Flo Microcatheter, Boston Scientific Corp (2000)

## Indications for use
Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment. The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure, values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.

Source page: https://510kreport.com/device/K112690
Methodology: https://510kreport.com/methodology