Class Class II
ZeroClear™ Bag Access (423100) (K243976)
Description
ZeroClear™ Bag Access (423100) by Epic Medical Pte. , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243976
Clearance Date2025-01-22
Clearance TypeSpecial
Product CodeONB
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243976
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. ZeroClear™ Bag Access (423100) (K243976) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241988 | ProSeal Closed System Bag Access | Epic Medical Pte. , Ltd. | 2024 |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016 |
Trace the full predicate network for K243976
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.