Class Class II
ProSeal™ Vented Universal Vial Adaptor (K240517)
Description
ProSeal™ Vented Universal Vial Adaptor by Epic Medical Pte. , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240517
Clearance Date2024-12-26
Clearance TypeTraditional
Product CodeONB
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240517
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. ProSeal™ Vented Universal Vial Adaptor (K240517) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241823 | ToxiSeal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024 |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 |
Trace the full predicate network for K240517
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.