# K123344: K-Shield Advantage Port Access Infusion Set (Pais)

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Mar 7, 2013 after 127 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: 1 generation back to K060580 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060580: K-Shield Port Access Infusion Set, Kawasumi Laboratories, Inc. (2006) Summary page 1.

## Most influential descendants
- K190233: K-Shield Advantage Port Access Infusion Set (PAIS) (2019), 0 descendants of its own

## Indications for use
The devices are used to administer solutions to a surgically implanted part.

Source page: https://510kreport.com/device/K123344
Methodology: https://510kreport.com/methodology