Class Class II
eZSURE™ Empty Fluid Container (K252094)
Description
eZSURE™ Empty Fluid Container by Epic Medical Pte. , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252094
Clearance Date2025-08-01
Clearance TypeSpecial
Product CodeKPE
Regulation Number880.5025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252094
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. eZSURE™ Empty Fluid Container (K252094) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241442 | eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. | 2024 |
| K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | 2024 |
| K230343 | ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. | 2023 |
| K223674 | eZSURE Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte. , Ltd. | 2023 |
Trace the full predicate network for K252094
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.