# K241613: Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hbcare Technology Co.,Ltd
- Decided: Oct 16, 2024 after 133 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: 6 generations back to K001670 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170151: Electronic Blood Pressure Monitor, Shenzhen Pango Electronic Co., Ltd. (2017) Summary page 5.

## Indications for use
The Electronic 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 is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 ~32 cm.

Source page: https://510kreport.com/device/K241613
Methodology: https://510kreport.com/methodology