# K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: May 9, 2008 after 106 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 K850316 (1985). 8 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003444: Model WS-500 Digital Wrist Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. (2000) Summary page 1.
- K071384: Modification to: Digital Blood Pressure Monitor, Model 1901, Nihon Seimitsu Sokki Co., Ltd. (2007) Summary page 1.
- K061403: Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1-4U, Microlife Intellectual Property GmbH (2006) Summary page 1.

## Most influential descendants
- K092161: Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF (2009), 14 descendants of its own
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT (2010), 12 descendants of its own
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- K113238: Full Automatic (Nibp) Blood Pressue Monitor (2012), 9 descendants of its own
- K142968: Full Automatic (NIBP) Blood Pressure Monitor (2014), 8 descendants of its own

## Indications for use
WS-1100/WS-1100PV system is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adults in a homecare environment. The device features include the display of irregular pulse rhythm detection, the classification display of measured blood pressure values against the guideline by World Health Organization or equivalent guidelines, the personal setting for individual blood pressure target values, the two memory banks to save the measurement results with date and time of measurement and the transferring the saved results to personal computers.

Source page: https://510kreport.com/device/K080177
Methodology: https://510kreport.com/methodology