# K231478: Digital Blood Pressure Monitor (Model: YB-800)

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Yosun Medical Technology Co.,Ltd
- Decided: Dec 15, 2023 after 207 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 K001670 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220886: Upper Arm Type  Blood Pressure Monitor, Shenzhen Jamr Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adults via non-invasive oscillometric technique in which an inflatable CUFF (22-32cm) is wrapped around the upper arm at medical facilities or at home, it's supplied for OTC use.

Source page: https://510kreport.com/device/K231478
Methodology: https://510kreport.com/methodology