FDA applicant
Premium Plastics, Inc.
FDA records 9 decisions for Premium Plastics, Inc. (Chicago, IL) from 1977 to 1995: 9 510(k) clearances. Most are in product codes BSY (Catheters, Suction, Tracheobronchial) and FNY (Basin, Emesis). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Premium Plastics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Premium Plastics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Premium Plastics, 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) ReportOther applicant names beginning “Premium”
FDA records each applicant name separately; these may or may not be the same firm.