510(k) Report

FDA applicant

Iv Medical, Inc.

Carlsbad, CA1 decision2003–20030 recalls

FDA records 1 decision for Iv Medical, Inc. (Carlsbad, CA) in 2003: 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 Iv Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Iv Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iv Medical, 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.

  • K030467Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension SetIv Medical, Inc. · 20031cites it

What has FDA decided for it lately?

  • K030467Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension SetIv Medical, Inc. · 2003

The one decision as Iv Medical, Inc. →