510(k) Report

FDA applicant

Hmi Industries, Inc.

Strongville, OH3 decisions1992–20010 recalls

FDA records 3 decisions for Hmi Industries, Inc. (Strongville, OH) from 1992 to 2001: 3 510(k) clearances. Most are in product codes FRF (Cleaner, Air, Medical Recirculating) and KZE (Injector, Fluid, Non-Electrically Powered). 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 Hmi Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hmi Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hmi Industries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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