# K254000: Happy Health Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Happy Health, Inc.
- Decided: Sep 3, 2026 after 262 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: 12 generations back to K962603 (1997). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250415: G0 Blood Pressure Monitoring System (G0), Aktiia SA (2025) Summary page 5.

## Indications for use
The Happy Health Blood Pressure Monitor is a software as a medical device (SaMD) intended to be used in patients who have a need for non-invasive blood pressure monitoring. The device is intended to be used on subjects aged 22 to 50 years old and analyzes acquired PPG, EDA, Accelerometer, and Skin Temperature signals from compatible, FDA cleared, hardware devices to derive spot-check measurements of systolic and diastolic blood pressure in a home or clinical setting. The Happy Health Blood Pressure Monitor is intended only for measurement and display; it makes no diagnosis. The device should not be used by individuals with arrhythmias such as atrial fibrillation, severe vascular disease or radial-artery abnormalities (e.g., Raynaud’s syndrome), under vasoactive drugs, or those who are pregnant. The Happy Health Blood Pressure Monitor is not intended to be used in conditions of motion or low perfusion.

Source page: https://510kreport.com/device/K254000
Methodology: https://510kreport.com/methodology