# K100720: K-Shield Port Access Infusion Set with High Pressure Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Nov 18, 2010 after 248 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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.
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple, C.R. Bard, Inc. (2006) Summary page 2.

## Recalls of this device
- Nov 25, 2013 · Class II · Z-0826-2014: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

## Indications for use
The K-Shield Port Access Infusion Set with High Pressure Tubing is an 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 high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. 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/K100720
Methodology: https://510kreport.com/methodology