510(k) Report

FDA applicant

Derata Corp.

Minneapolis, MN6 decisions1977–19880 recalls

FDA records 6 decisions for Derata Corp. (Minneapolis, MN) from 1977 to 1988: 6 510(k) clearances. All are in product code KZE (Injector, Fluid, Non-Electrically Powered). 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 Derata Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Derata Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Derata Corp. 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?

  • KZEInjector, Fluid, Non-Electrically Powered6decisions

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K883847Derata Medi-Jector VDerata Corp. · 19882cite it
  • K864561Derata Medi-Jector IVDerata Corp. · 19872cite it

What has FDA decided for it lately?

  • K883847Derata Medi-Jector VDerata Corp. · 1988
  • K864561Derata Medi-Jector IVDerata Corp. · 1987
  • K844244Derata Medi-Jector ProDerata Corp. · 1985
  • K844111Derata Medi-Jector IiiDerata Corp. · 1984
  • K834044Medi-Jector IIDerata Corp. · 1984
  • K772129Medi-JectorDerata Corp. · 1977

All 6 as Derata Corp. →