# K860272: Solution Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Mar 18, 1986 after 50 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 30, 2015 · Class II · Z-0605-2016: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
- Nov 30, 2015 · Class II · Z-0606-2016: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
- Dec 6, 2011 · Not classified · Z-0472-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Dec 6, 2011 · Not classified · Z-0473-2012: During production of the IV sets, solvent was inadvertently applied to the locking collar of the male luer connector, which may have damaged the component, preventing proper engagement of the locking 
- Aug 3, 2005 · Not classified · Z-1425-05: 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-1426-05: 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-1427-05: 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-1150-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Source page: https://510kreport.com/device/K860272
Methodology: https://510kreport.com/methodology