# K020251: Paragon Infusion System

- Pathway: 510(k) (Special)
- Applicant: I-Flow Corp.
- Decided: Feb 15, 2002 after 22 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
Longest line of descent: 4 generations back to K896422 (1990). 13 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 22 devices in its family (counting itself) has 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.
- K984146: Paragon Infusion, I-Flow Corp. (1999) Summary page 1.
- K984063: Paragon Basal/Bolus Administration Set, I-Flow Corp. (1999) Summary page 1.
- K984638: Paragon Bolus Accessory Set, I-Flow Corp. (1999) Summary page 1.
- K960318: Dib Infusor-RA, Novacon Corp. (1996) Summary page 1.
- K890489: Extension Set W/Flow Regulator, Baxter Healthcare Corp (1989) Summary page 1.

## Most influential descendants
- K052451: MPS Acacia Medflo Elastomeric Pump (2005), 5 descendants of its own
- K081905: Accuflow and Accuflux Elastomeric Infusion Pump (2008), 4 descendants of its own
- K151650: SMARTez elastomeric infusion pump (2016), 3 descendants of its own
- K250234: SMARTeZ™ Elastomeric Infusion Pump (RS series) (2026), 0 descendants of its own
- K240624: InfuLife (2024), 0 descendants of its own

## Indications for use
The Paragon Infusion System is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, subcutaneous, intramuscular and epidural. The Paragon Infusion System is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous.

Source page: https://510kreport.com/device/K020251
Methodology: https://510kreport.com/methodology