FDA applicant

Ani OY

Canada M1x 1b4, CA2 decisions1992–20260 recalls

FDA records 2 decisions for Ani OY (Canada M1x 1b4, CA) from 1992 to 2026: 2 510(k) clearances. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and PEM (Dental Barriers And Sleeves). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “ANI Co., Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Ani OY

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?