510(k) Report

FDA applicant

Polymer Technology Corp.

Rochester, NY28 decisions1983–20013 recalls

FDA records 28 decisions for Polymer Technology Corp. (Rochester, NY) from 1983 to 2001: 28 510(k) clearances. Most are in product codes HQD (Lens, Contact (Other Material) - Daily) and CGA (Glucose Oxidase, Glucose). Its devices cite 8 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Polymer Technology”.

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 Polymer Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polymer Technology Corp. since 2007.

Recalls per year

1in 2017

2010: 12016: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Polymer Technology 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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Other applicant names beginning “Polymer”

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