FDA 510(k) · Happy Health
K254000: Happy Health Blood Pressure Monitor (Happy Health, Inc.)
Happy Health, Inc. received FDA 510(k) K254000 for Happy Health Blood Pressure Monitor, with a decision date of Sep 3, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254000 |
|---|---|
| Pathway | 510(k) |
| Applicant | Happy Health, Inc. |
| Device name | Happy Health Blood Pressure Monitor |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Dec 15, 2025 |
| Decision date | Sep 3, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.