FDA cleared the Happy Health Blood Pressure Monitor from Happy Health, Inc. on Sep 3, 2026 under K254000, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.
FDA logged the submission as received on Dec 15, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Happy Health, Inc. in the last 12 months of the tracker.