# K182018: Bluetooth blood pressure monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Kingyield Technology Co., Ltd.
- Decided: Oct 6, 2018 after 71 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: 3 generations back to K042505 (2005). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112042: Kingyield Wrist Blood Pressure Monitor, Shenzhen Kingyield Technology Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- 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

## Indications for use
This blood pressure monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.

Source page: https://510kreport.com/device/K182018
Methodology: https://510kreport.com/methodology