Class Class U
NovoSorb BTM (K251567)
Description
NovoSorb BTM by Polynovo Biomaterials Pty, Ltd., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK251567
Clearance Date2025-06-20
Clearance TypeSpecial
Product CodeQSZ
FDA Database
View on FDA DatabasePredicate lineage for K251567
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. NovoSorb BTM (K251567) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | 2025 |
| K173544 | Phoenix Wound Matrix | Nanofiber Solutions, Inc. | 2018 |
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound... | Polynovo Biomaterials Pty, Ltd. | 2017 |
Trace the full predicate network for K251567
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.