Class Class II
Chemfort Female Luer Lock Adaptor (K251411)
Description
Chemfort Female Luer Lock Adaptor by Simplivia Healthcare , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251411
Clearance Date2025-08-05
Clearance TypeTraditional
Product CodeONB
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251411
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. Chemfort Female Luer Lock Adaptor (K251411) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192866 | Chemfort CSTD | Simplivia Healthcare , Ltd. | 2020 |
Trace the full predicate network for K251411
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.