# K964850: Solution Administration Set with 0.22 Micron High Pressure Extended Life Filter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Feb 25, 1997 after 84 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960466 (1996). 1 ancestor in all.
2 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)
- K960466: Ivex-2 Extension Set with Y-Injection Site (Modification), Abbott Laboratories (1996) Summary page 1.
- (no number) Baxter Solution Sets with 0.22 Micron Filter: named in the summary without a submission number

## Most influential descendants
- K153158: Solution Administration Sets with 0.2 Micron Filter (2015), 0 descendants of its own
- K994429: Venusa, LTD. Extension Set with Filter (2000), 0 descendants of its own

## Recalls of this device
- Dec 15, 2005 · Not classified · Z-0641-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0642-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Dec 15, 2005 · Not classified · Z-0652-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Jul 6, 2005 · Not classified · Z-1100-05: Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
- Jul 16, 2003 · Not classified · Z-1153-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

## Indications for use
The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions.

Source page: https://510kreport.com/device/K964850
Methodology: https://510kreport.com/methodology