FDA applicant

Ivion Corp.

Broomfield, CO3 decisions1992–19930 recalls

FDA records 3 decisions for Ivion Corp. (Broomfield, CO) from 1992 to 1993: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LJT (Port & Catheter, Implanted, Subcutaneous…). 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 Ivion Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivion Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ivion Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Ivion Corp.

Which product codes does it file in?

What has FDA decided for it lately?