# K160007: Paclitaxel Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Dec 19, 2016 after 350 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 K832284 (1983). 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)
- K981792: Solution Administration Set, Baxter Healthcare Corp (1998) Summary page 5.

## Indications for use
To administer fluids with Baxter infusion pumps to a patient’s vascular system from a container though a needle or catheter inserted into a vein, primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.

Source page: https://510kreport.com/device/K160007
Methodology: https://510kreport.com/methodology