Class Class II
BiliWrap (K243372)
Description
BiliWrap by Gerium Medical, Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243372
Clearance Date2025-05-29
Clearance TypeTraditional
Product CodeLBI
Regulation Number880.5700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243372
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. BiliWrap (K243372) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210289 | Infant Phototherapy Equipment | Bistos Co., Ltd. | 2021 |
Trace the full predicate network for K243372
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.