FDA applicant

Bionaire Corp.

Lachine H8t 3h7, CA2 decisions1994–19940 recalls

FDA records 2 decisions for Bionaire Corp. (Lachine H8t 3h7, CA) in 1994: 2 510(k) clearances. All are in product code FRF (Cleaner, Air, Medical Recirculating). 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 Bionaire Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bionaire Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Bionaire Corp.

Which product codes does it file in?

What has FDA decided for it lately?