# K083043: King`Yield Wrist Blood Pressure Monitor, Model BP201

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kingyield Technology Co., Ltd.
- Decided: Oct 27, 2008 after 13 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 K042505 (2005). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042505: Omron Digital Wrist Blood Pressure Monitor, Model Hem-609N, Omron Healthcare, Inc. (2005) Summary page 2.

## Most influential descendants
- K112042: Kingyield Wrist Blood Pressure Monitor (2012), 3 descendants of its own
- K182018: Bluetooth blood pressure monitor (2018), 2 descendants of its own
- K231367: Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) (2023), 1 descendant of its own
- K254048: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) (2026), 0 descendants of its own
- K152415: Digital Blood Pressure Monitor (2016), 0 descendants of its own

## Indications for use
It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate. The device is intended for use in only adult population, not applied to the other populations such as neonatal baby. It can not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Source page: https://510kreport.com/device/K083043
Methodology: https://510kreport.com/methodology