# K963355: Solopak Paragon Infusor Pump and Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Solopak Medical Products, Inc.
- Decided: Oct 4, 1996 after 39 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 K923875 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923875: Sidekick 50 Plus and Sidekick 100 Plus, I-Flow Corp. (1993) Summary page 1.

## Indications for use
The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.

Source page: https://510kreport.com/device/K963355
Methodology: https://510kreport.com/methodology