# K112620: Disital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Aug 2, 2012 after 329 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: 6 generations back to K850316 (1985). 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)
- K993890: Digital Blood Pressure Monitor, Model DS-181, Nihon Seimitsu Sokki Co., Ltd. (1999) Summary page 1.
- K112691: Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. (2012). Cleared while this submission was under review
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV, Nihon Seimitsu Sokki Co., Ltd. (2008) Summary page 1.
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.

## Indications for use
Blood Pressure Monitor DSK-1031 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) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.

Source page: https://510kreport.com/device/K112620
Methodology: https://510kreport.com/methodology