510(k) Report

FDA applicant

S. M. C. Medi-Tech Corp.

Grand Prairie, TX2 decisions1987–19870 recalls

FDA records 2 decisions for S. M. C. Medi-Tech Corp. (Grand Prairie, TX) in 1987: 2 510(k) clearances. Most are in product codes KYE (Inserter/Remover Contact Lens) and LPN (Accessories, Soft Lens Products). 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 S. M. C. Medi-Tech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S. M. C. Medi-Tech Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S. M. C. Medi-Tech Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like S. M. C. Medi-Tech Corp.’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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