# K984146: Paragon Infusion

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Feb 9, 1999 after 82 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896422 (1990). 6 ancestors in all.
11 later devices descend from it; 3 cite it directly.
1 of 18 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 2.
- K980558: Painbuster Infusion System, I-Flow Corp. (1998) Summary page 2.
- K982946: Painbuster Infusion Kit, I-Flow Corp. (1998) Summary page 2.
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 2.
- K944692: C-Series Homepump, Block Medical, Inc. (1995) Summary page 2.

## Most influential descendants
- K020251: Paragon Infusion System (2002), 8 descendants of its own
- 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

## Indications for use
The Paragon Infusion Kit is intended to provide continuous infusion a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

Source page: https://510kreport.com/device/K984146
Methodology: https://510kreport.com/methodology