Class Class II
Belun Sleep System BLS-100 (K222579)
Description
Belun Sleep System BLS-100 by Belun Technology Company Limited, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222579
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222579
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. Belun Sleep System BLS-100 (K222579) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220028 | NightOwl | Ectosense NV | 2022 |
| K183625 | SomnaPatch | Respironics, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025 |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | 2025 |
Trace the full predicate network for K222579
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.