# K112691: 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: 5 generations back to K850316 (1985). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071384: Modification to: Digital Blood Pressure Monitor, Model 1901, Nihon Seimitsu Sokki Co., Ltd. (2007) Summary page 1.
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, Nihon Seimitsu Sokki Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K112620: Disital Blood Pressure Monitor (2012), 0 descendants of its own

## Indications for use
Blood Pressure Monitor DSK-101 1 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/K112691
Methodology: https://510kreport.com/methodology