510(k) Report

FDA applicant

Gorman Rupp Industries

Mchenry, IL6 decisions1976–19770 recalls

FDA records 6 decisions for Gorman Rupp Industries (Mchenry, IL) from 1976 to 1977: 6 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and BSB (Warmer, Blood, Non-Electromagnetic Radiation). 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 Gorman Rupp Industries’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gorman Rupp Industries since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gorman Rupp Industries 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?

  • DWJSystem, Thermal Regulating3decisions
  • BSBWarmer, Blood, Non-Electromagnetic Radiation1decision
  • ILOPack, Hot Or Cold, Water Circulating1decision
  • JRRRegulator, Temperature1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K770232Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 19773cite it

What has FDA decided for it lately?

  • K771537Aquamatic K-Module Model K-20Gorman Rupp Industries · 1977
  • K770839Aquamatic K-77Gorman Rupp Industries · 1977
  • K770232Blood/Fluid Warmer Model DW-1000AGorman Rupp Industries · 1977
  • K761337Aquamatic K-Module Model K-10Gorman Rupp Industries · 1977
  • K760910Disposable K-PadsGorman Rupp Industries · 1976
  • K761087Electronic Control UnitGorman Rupp Industries · 1976

All 6 as Gorman Rupp Industries →