# K882302: Ivac (R) Unvented Vol. Infusion Set Model 52080

- Pathway: 510(k) (Traditional)
- Applicant: Y
- Decided: Jul 12, 1988 after 40 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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
- K050115: Blood Hand Pump Administration Set (2005), 7 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own
- K153731: LifeFlow Rapid Infusion Device (LifeFlow Device) (2016), 1 descendant of its own
- K213588: Q2 IV Administration Sets (2022), 0 descendants of its own

## Recalls of this device
- Oct 11, 2023 · Class II · Z-0350-2024: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
- Dec 20, 2012 · Class II · Z-0832-2013: CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observ

Source page: https://510kreport.com/device/K882302
Methodology: https://510kreport.com/methodology