Cleared Traditional

Happy Health Home Sleep Test

K242224 · Happy Health, Inc. · Anesthesiology
Jun 2025
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K242224 is an FDA 510(k) clearance for the Happy Health Home Sleep Test, a Ventilatory Effort Recorder (Class II — Special Controls, product code MNR), submitted by Happy Health, Inc. (Austin, US). The FDA issued a Cleared decision on June 18, 2025, 324 days after receiving the submission on July 29, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K242224 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2024
Decision Date June 18, 2025
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNR — Ventilatory Effort Recorder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375