510(k) Report

FDA applicant

Infusion Devices, Inc.

Mccordsville, IN1 decision2001–20010 recalls

FDA records 1 decision for Infusion Devices, Inc. (Mccordsville, IN) in 2001: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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 Infusion Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Infusion Devices, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Infusion Devices, 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?

  • FPASet, Administration, Intravascular1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K003854Intravascular Administration SetInfusion Devices, Inc. · 20011cites it

What has FDA decided for it lately?

  • K003854Intravascular Administration SetInfusion Devices, Inc. · 2001

The one decision as Infusion Devices, Inc. →

Other applicant names beginning “Infusion”

FDA records each applicant name separately; these may or may not be the same firm.

Infusion Dynamics, Inc. 3Infusion Technology Intl. 3Infusion Systems Corp. 2Infusion Safety Products, Inc. 1