FDA applicant

Infinitech, Inc.

Chesterfield, MO6 decisions1994–19970 recalls

FDA records 6 decisions for Infinitech, Inc. (Chesterfield, MO) from 1994 to 1997: 6 510(k) clearances. Most are in product codes MPA (Endoilluminator) and HQF (Laser, Ophthalmic). Its devices cite 3 predicates, 0 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Infinitech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Infinitech, Inc.’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

Infinitech, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?