# K251340: ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

- Pathway: 510(k) (Special)
- Applicant: Epic Medical Pte., Ltd.
- Decided: May 29, 2025 after 29 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K883614 (1988). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241988: ProSeal™ Closed System Bag Access, Epic Medical Pte., Ltd. (2024) Summary page 5.

## Indications for use
The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

Source page: https://510kreport.com/device/K251340
Methodology: https://510kreport.com/methodology