# K984063: Paragon Basal/Bolus Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: I-Flow Corp.
- Decided: Feb 9, 1999 after 85 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.
9 later devices descend from it; 1 cites it directly.
1 of 16 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). Cleared while this submission was under review 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 Basal/Bolus Administration Set is intended to provide a continuous, basal level infusion of medication and to allow patient controlled bolus delivery. The bolus component of the administration set enables fixed boluses of medication to be delivered upon demand by the patient or healthcare provider. The Paragon Basal/Bolus Administration Set routes of administration include: intravenous, epidural, intramuscular and subcutaneous.

Source page: https://510kreport.com/device/K984063
Methodology: https://510kreport.com/methodology