Class Class II
ProSeal™ Closed System Bag Access (K241988)
Description
ProSeal™ Closed System Bag Access by Epic Medical Pte. , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241988
Clearance Date2024-10-23
Clearance TypeTraditional
Product CodeONB
Regulation Number880.5440
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241988
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™ Closed System Bag Access (K241988) cites 3 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241823 | ToxiSeal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024 |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | 2024 |
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co... | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | 2025 |
| K243976 | ZeroClear Bag Access (423100) | Epic Medical Pte. , Ltd. | 2025 |
Trace the full predicate network for K241988
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.