# K962663: Solopak Sidekick Infusion Pump and Administation Set

- Pathway: 510(k) (Traditional)
- Applicant: Solopak Medical Products, Inc.
- Decided: Oct 4, 1996 after 88 days
- Product code: MEB (Pump, Infusion, Elastomeric)
- 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
Longest line of descent: 1 generation back to K915646 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K915646: Vivus 50 and Vivus 100 Personal Infuser, I-Flow Corp. (1992) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml).

Source page: https://510kreport.com/device/K962663
Methodology: https://510kreport.com/methodology