# K230343: ProSeal™ Closed System Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Nov 3, 2023 after 268 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 4 generations back to K832284 (1983). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151151: U & U Intravascular Administration Set, U&U Medical Technology Co, Ltd. (2015) Summary page 5.

## Most influential descendants
- K251814: EZ™ IV Administration Set (2025), 0 descendants of its own

## Indications for use
The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

Source page: https://510kreport.com/device/K230343
Methodology: https://510kreport.com/methodology