510(k) Report

FDA applicant

Ohio Medical Corporation

Gurnee, IL2 decisions2006–20084 recalls

FDA records 2 decisions for Ohio Medical Corporation (Gurnee, IL) from 2006 to 2008: 2 510(k) clearances. All are in product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2010: 32018: 1
2007high 3 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Ohio”

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