510(k) Report

FDA applicant

Medroyal, Inc.

Powell, TN1 decision1992–19920 recalls

FDA records 1 decision for Medroyal, Inc. (Powell, TN) in 1992: 1 510(k) clearance. All are in product code DXT (Injector And Syringe, Angiographic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Medroyal, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medroyal, 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) Report

Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K920135Medroyal Angiographic Control SyringeMedroyal, Inc. · 19921cites it

What has FDA decided for it lately?

  • K920135Medroyal Angiographic Control SyringeMedroyal, Inc. · 1992

The one decision as Medroyal, Inc. →