# K811885: 30-30-2 700 Syringe Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Y
- Decided: Aug 25, 1981 after 55 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 7 (1 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.
1 of 1 device in its family (counting itself) has 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
- Aug 2, 2021 · Class II · Z-2457-2021: Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy 
- Apr 9, 2020 · Class II · Z-1967-2020: The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence
- Apr 9, 2020 · Class II · Z-1968-2020: The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence
- Apr 9, 2020 · Class II · Z-1969-2020: The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence
- Feb 28, 2019 · Class I · Z-1210-2019: Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
- Sep 26, 2018 · Class II · Z-0386-2019: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.
- Sep 26, 2018 · Class II · Z-0387-2019: The products have the potential to leak between the connection of the male luer lock and the yellow striped tubing.

Source page: https://510kreport.com/device/K811885
Methodology: https://510kreport.com/methodology