510(k) Report

FDA applicant

Ingenious Technologies Corp.

Massillon, OH2 decisions1992–19940 recalls

FDA records 2 decisions for Ingenious Technologies Corp. (Massillon, OH) from 1992 to 1994: 2 510(k) clearances. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Ingenious Technologies Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ingenious Technologies Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ingenious Technologies 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?

  • FMINeedle, Hypodermic, Single Lumen2decisions

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.

  • K936235Needlesafe II & Needlegard IIIngenious Technologies Corp. · 19941cites it

What has FDA decided for it lately?

  • K936235Needlesafe II & Needlegard IIIngenious Technologies Corp. · 1994
  • K920717Needlegard IIIngenious Technologies Corp. · 1992

All 2 as Ingenious Technologies Corp. →