# K003444: Model WS-500 Digital Wrist Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Nov 21, 2000 after 15 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
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV (2008), 19 descendants of its own
- 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

Source page: https://510kreport.com/device/K003444
Methodology: https://510kreport.com/methodology