510(k) Report

FDA applicant

Coburn Optical Ind., Inc.

Mchenry, IL14 decisions1978–19890 recalls

FDA records 14 decisions for Coburn Optical Ind., Inc. (Mchenry, IL) from 1978 to 1989: 14 510(k) clearances. Most are in product codes HJG (System, Reading, Television, Closed-Circuit) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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, ophthalmic panel, where it files most

How often FDA has decided Coburn Optical Ind., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coburn Optical Ind., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Coburn Optical Ind., 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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