# K252769: Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Finicare Co., Ltd.
- Decided: Oct 2, 2025 after 30 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: 9 generations back to K001182 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220113: Upper Arm Electronic Blood Pressure Monitor (Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112), Shenzhen Finicare Co., Ltd. (2022) Summary page 6.

## Indications for use
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP107, FC-BP123, FC-BP125, FC-BP126,FC-BP127, FC-BP116 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices’ features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.

Source page: https://510kreport.com/device/K252769
Methodology: https://510kreport.com/methodology