# K060580: K-Shield Port Access Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Jun 6, 2006 after 92 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Exel Int Secure Touch Safety Huber Infusion Set: named in the summary without a submission number

## Most influential descendants
- K123344: K-Shield Advantage Port Access Infusion Set (Pais) (2013), 1 descendant of its own
- K190233: K-Shield Advantage Port Access Infusion Set (PAIS) (2019), 0 descendants of its own
- K100720: K-Shield Port Access Infusion Set with High Pressure Tubing (2010), 0 descendants of its own

## Indications for use
The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

Source page: https://510kreport.com/device/K060580
Methodology: https://510kreport.com/methodology