# K832284: Solution Admin. Set 2C9096 W/10 PVC

- Pathway: 510(k) (Traditional)
- Applicant: Travenol Laboratories, S.A.
- Decided: Dec 29, 1983 after 169 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
2 of 17 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
- K981792: Solution Administration Set (1998), 14 descendants of its own
- K120685: Zyno Medical Administration Set (2012), 12 descendants of its own
- K151151: U & U Intravascular Administration Set (2015), 5 descendants of its own
- K232316: DEKA Infusion System, DEKA Administration Set (2024), 1 descendant of its own
- K230343: ProSeal™ Closed System Administration Set (2023), 1 descendant of its own

## Recalls of this device
- Apr 28, 2004 · Not classified · Z-0193-05: Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
- Jul 16, 2003 · Not classified · Z-1157-03: 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/K832284
Methodology: https://510kreport.com/methodology