# K250415: G0 Blood Pressure Monitoring System (G0)

- Pathway: 510(k) (Traditional)
- Applicant: Aktiia SA
- Decided: Jul 2, 2025 after 139 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: 11 generations back to K962603 (1997). 83 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190792: BB-613WP, Biobeat Technologies, Ltd. (2019) Summary page 5.
- K240254: Blood Pressure Monitor (TMB-2296-BT), Guangdong Transtek Medical Electronics Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K254000: Happy Health Blood Pressure Monitor (2026), 0 descendants of its own

## Indications for use
The Aktiia GO Blood pressure monitoring system consists of a wrist worn monitor and an oscillometric cuff. The system is intended for measuring blood pressure and pulse rate based on using a Pulse Wave technique in adults aged from 22 to 59 years old with wrist circumference ranging from 14 cm to 21 cm following a calibration process (every 24 hours) using the oscillometric blood pressure cuff. The Aktiia GO Blood pressure monitoring system is intended for spot-checking of adult patients for home use.

Source page: https://510kreport.com/device/K250415
Methodology: https://510kreport.com/methodology