FDA applicant

Empire Plastics Manufacturer

Mchenry, IL4 decisions1979–19790 recalls

FDA records 4 decisions for Empire Plastics Manufacturer (Mchenry, IL) in 1979: 4 510(k) clearances. Most are in product codes BWF (Spirometer, Therapeutic (Incentive)) and BZK (Spirometer, Monitoring (W/Wo Alarm)). 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, anesthesiology panel, where it files most

How often FDA has decided Empire Plastics Manufacturer’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Empire Plastics Manufacturer since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Empire Plastics Manufacturer’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 “Empire”

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

Empire Industries, Inc. 3

Empire Plastics Manufacturer

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Empire”