FDA applicant

Epica International, Inc.

San Clemente, CA2 decisions2019–20240 recalls

FDA records 2 decisions for Epica International, Inc. (San Clemente, CA) from 2019 to 2024: 2 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 2 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, radiology panel, where it files most

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

FDA decisions per year

1in 2024

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Epica International, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Epica International, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?