510(k) Report

FDA applicant

Advanced Infusion, Inc.

Tempe, AZ6 decisions1999–20080 recalls

FDA records 6 decisions for Advanced Infusion, Inc. (Tempe, AZ) from 1999 to 2008: 6 510(k) clearances. Most are in product codes MEB (Pump, Infusion, Elastomeric) and MED (Sterilant, Medical Devices). Its devices cite 22 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Advanced Infusion, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Infusion, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MEBPump, Infusion, Elastomeric5decisions
  • MEDSterilant, Medical Devices1decision

Whose devices does it build on?

Its devices cite 22 predicates; 6 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021964Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 20024cite it
  • K992551Alpha Infusion PumpAdvanced Infusion, Inc. · 19991cites it
  • K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 20041cites it

What has FDA decided for it lately?

  • K071532Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008
  • K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
  • K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip…Advanced Infusion, Inc. · 2006
  • K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
  • K021964Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
  • K992551Alpha Infusion PumpAdvanced Infusion, Inc. · 1999

All 6 as Advanced Infusion, Inc. →