FDA applicant

Optikem Polymers, Inc.

Englewood, CO1 decision1990–19900 recalls

FDA records 1 decision for Optikem Polymers, Inc. (Englewood, CO) in 1990: 1 510(k) clearance. All are in product code HPX (Lens, Contact (Polymethylmethacrylate)). No recall is linked to its devices.

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

How often FDA has decided Optikem Polymers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optikem Polymers, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Optikem”

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

Optikem International, Inc. 2

Optikem Polymers, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Optikem”