# K241578: Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bsx Technology Electronics Co., Ltd.
- Decided: Feb 19, 2025 after 261 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.
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)
- K182127: Wrist Blood Pressure Monitor Model BP6100, Omron Healthcare, Inc. (2018) Summary page 5.

## Indications for use
The Wrist Digital Blood Pressure Monitor (Model: BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX359) is a digital and non-invasive monitor intended to measure the diastolic, systolic blood pressure and pulse rate in adult with an inflatable wrist cuff circumference ranging from 13.5 to 19.5cm. It is intended for clinical and home use.

Source page: https://510kreport.com/device/K241578
Methodology: https://510kreport.com/methodology