# K153158: Solution Administration Sets with 0.2 Micron Filter

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Dec 28, 2015 after 56 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960466 (1996). 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)
- K964850: Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter, Baxter Healthcare Corp (1997) Summary page 5.

## Recalls of this device
- Aug 29, 2025 · Class II · Z-0196-2026: IV sets may leak.
- Aug 29, 2025 · Class II · Z-0195-2026: IV sets may leak.

## Indications for use
For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

Source page: https://510kreport.com/device/K153158
Methodology: https://510kreport.com/methodology