510(k) Report

FDA applicant

Polymint Industrial Co., Ltd.

Golden,, CO5 decisions1989–19940 recalls

FDA records 5 decisions for Polymint Industrial Co., Ltd. (Golden,, CO) from 1989 to 1994: 5 510(k) clearances. Most are in product codes LRR (First Aid Kit With Drug) and FPX (Strip, Adhesive, Closure, Skin). 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, general hospital panel, where it files most

How often FDA has decided Polymint Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Polymint Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Polymint Industrial Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Polymint Industrial Co., Ltd.’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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