510(k) Report

FDA applicant

Royal Precision Plastics, Inc.

Powell, TN1 decision1994–19940 recalls

FDA records 1 decision for Royal Precision Plastics, Inc. (Powell, TN) in 1994: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). 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 Royal Precision Plastics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Royal Precision Plastics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

What has FDA decided for it lately?

  • K934252Rppi Sterilization BagsRoyal Precision Plastics, Inc. · 1994

The one decision as Royal Precision Plastics, Inc. →

Other applicant names beginning “Royal”

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

Royal American Industries, Inc. 2Royal Enterprises Manufacturing, Inc. 2Royal Oak Medical Devices 2Royal King Infant Products Co., Ltd. 1Royal Flash Enterprise Co., Ltd. 1Royal Industries (Thailand) Public Co., Ltd. 1Royal Shine Enterprises, Ltd. 1Royal Scientific, Inc. 1Royal Dental Lab 1Royal Plastic Sarl 1Royal Pacific Intl. Trade, Inc. 1