# K992551: Alpha Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Infusion, Inc.
- Decided: Oct 27, 1999 after 89 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: 2 generations back to K896422 (1990). 8 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K922382: Intermate (R) LV Elastomeric Infusion Device, Baxter Healthcare Corp (1993) Summary page 2.
- K980558: Painbuster Infusion System, I-Flow Corp. (1998) Summary page 2.
- K896422: Burron Ambulatory Drug Delivery System, Burron Medical, Inc. (1990) Summary page 2.
- K990101: Pain Control Infusion Pump, Sgarlato Laboratories, Inc. (1999) Summary page 2.
- K982256: Outbound Disposable Syringe Infuser Outbound 2 Disposable Pump, Mckinley, Inc. (1998) Summary page 2.
- K983454: Pain Care 2000, Breg, Inc. (1998) Summary page 2.

## Most influential descendants
- K021964: Alpha Infusion Pump and Catheters (2002), 4 descendants of its own
- 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 is 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 percutaneously through a catheter. The Alpha Infusion Pump is suitable for usc as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment

Source page: https://510kreport.com/device/K992551
Methodology: https://510kreport.com/methodology