510(k) Report

FDA applicant

Academic Catalyst Corp.

Valhalla, NY1 decision1990–19900 recalls

FDA records 1 decision for Academic Catalyst Corp. (Valhalla, NY) in 1990: 1 510(k) clearance. All are in product code HJI (Lens, Fundus, Hruby, Diagnostic). 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, ophthalmic panel, where it files most

How often FDA has decided Academic Catalyst Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Academic Catalyst Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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