# K791496: Low Plasticizer Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Apr 8, 1980 after 249 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K172544: IV Fat Emulsion Administration Sets (2017), 0 descendants of its own

## Recalls of this device
- Dec 15, 2005 · Not classified · Z-0626-06: 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-0629-06: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
- Aug 3, 2005 · Not classified · Z-1424-05: 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-1103-05: 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.
- Mar 3, 2005 · Not classified · Z-0854-05: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Feb 28, 2005 · Not classified · Z-0845-05: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
- Jan 20, 2005 · Not classified · Z-0694-05: Product older than three years may not operate as intended.
- Oct 17, 2002 · Not classified · Z-0517-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0519-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0520-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0521-03: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Oct 17, 2002 · Not classified · Z-0518-03: 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/K791496
Methodology: https://510kreport.com/methodology