# K071532: Alpha Infusion Pump,  Model A200, A450

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Infusion, Inc.
- Decided: Feb 19, 2008 after 259 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: 4 generations back to K896422 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021964: Alpha Infusion Pump and Catheters, Advanced Infusion, Inc. (2002) Summary page 1.
- K003915: Accufuser; Accufuser Plus, Help Technologies (2001)

## Indications for use
The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

Source page: https://510kreport.com/device/K071532
Methodology: https://510kreport.com/methodology