# K915646: Vivus 50 and Vivus 100 Personal Infuser

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Jun 15, 1992 after 180 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962663: Solopak Sidekick Infusion Pump and Administation Set (1996), 2 descendants of its own
- K990889: Autodose Infusion System (1999), 1 descendant of its own
- K993832: Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10 (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K915646
Methodology: https://510kreport.com/methodology