# K021964: Alpha Infusion Pump and Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Infusion, Inc.
- Decided: Aug 12, 2002 after 59 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: 3 generations back to K896422 (1990). 9 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992551: Alpha Infusion Pump, Advanced Infusion, Inc. (1999) Summary page 1.

## Most influential descendants
- K042246: Multi-Drip Infusion Catheter (2004), 1 descendant of its own
- K071532: Alpha Infusion Pump,  Model A200, A450 (2008), 0 descendants of its own
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own
- K061356: Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6 (2006), 0 descendants of its own

## Indications for use
The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment

Source page: https://510kreport.com/device/K021964
Methodology: https://510kreport.com/methodology