Class Class U
Helios Dermal Scaffold (K250397)
Description
Helios Dermal Scaffold by Helios Biomedical, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK250397
Clearance Date2025-08-15
Clearance TypeTraditional
Product CodeKGN
FDA Database
View on FDA DatabasePredicate lineage for K250397
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. Helios Dermal Scaffold (K250397) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix | Helios Cardio, Inc. | 2021 |
| K153690 | PriMatrix Dermal Repair Scaffold | Tei Biosciences, Inc. | 2016 |
Trace the full predicate network for K250397
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.