Class Class II
Happy Health Home Sleep Test (K242224)
Description
Happy Health Home Sleep Test by Happy Health, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242224
Clearance Date2025-06-18
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242224
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Happy Health Home Sleep Test (K242224) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024 |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023 |
| K191031 | NightOwl | Ectosense NV | 2020 |
Trace the full predicate network for K242224
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.