FDA applicant

Plasco, Inc.

Gurnee, IL16 decisions1983–19980 recalls

FDA records 16 decisions for Plasco, Inc. (Gurnee, IL) from 1983 to 1998: 16 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and KNX (Collector, Urine, (And Accessories) For…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Plasco, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Plasco, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?