510(k) Report

FDA applicant

Ohio Medical Instrument Co., Inc.

Cincinnati, OH19 decisions1983–20023 recalls

FDA records 19 decisions for Ohio Medical Instrument Co., Inc. (Cincinnati, OH) from 1983 to 2002: 19 510(k) clearances. Most are in product codes HBL (Holder, Head, Neurosurgical (Skull Clamp)) and HAW (Neurological Stereotaxic Instrument). Its devices cite 13 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Ohio Medical Instrument Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ohio Medical Instrument Co., Inc. since 2007.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ohio Medical Instrument Co., 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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Other applicant names beginning “Ohio”

FDA records each applicant name separately; these may or may not be the same firm.