# K190233: K-Shield Advantage Port Access Infusion Set (PAIS)

- Pathway: 510(k) (Special)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: May 2, 2019 after 85 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: 2 generations back to K060580 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123344: K-Shield Advantage Port Access Infusion Set (Pais), Kawasumi Laboratories, Inc. (2013) Summary page 4.

## Indications for use
The K-Shield Advantage Port Access Infusion Set (PAILS) is a safety port access device used to administer solutions to surgically implanted port.

Source page: https://510kreport.com/device/K190233
Methodology: https://510kreport.com/methodology