# K924721: Baxter Solution Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 20, 1993 after 302 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
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023039: Blood/Solution Administration Set, Model 33.015 (2002), 2 descendants of its own
- K041496: Pentatrasfu  Blood Transfusion Sets (2005), 1 descendant of its own
- K083349: Blood Transfusion Set (2009), 0 descendants of its own

## Recalls of this device
- Dec 15, 2005 · Not classified · Z-0646-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Jul 16, 2003 · Not classified · Z-1154-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1165-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Jul 16, 2003 · Not classified · Z-1155-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
- Oct 17, 2002 · Not classified · Z-0516-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

Source page: https://510kreport.com/device/K924721
Methodology: https://510kreport.com/methodology