510(k) Report

FDA applicant

Felton International, Inc.

Lenexa, KS2 decisions2001–20040 recalls

FDA records 2 decisions for Felton International, Inc. (Lenexa, KS) from 2001 to 2004: 2 510(k) clearances. All are in product code KZE (Injector, Fluid, Non-Electrically Powered). Its devices cite 2 predicates, 1 of them its own earlier devices. 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 Felton International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Felton International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Felton International, 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?

  • KZEInjector, Fluid, Non-Electrically Powered2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013256BI-3M Needle-Free Injector SystemFelton International, Inc. · 20011cites it

What has FDA decided for it lately?

  • K041280Human Subcutaneous Injector, Model Hsi 500Felton International, Inc. · 2004
  • K013256BI-3M Needle-Free Injector SystemFelton International, Inc. · 2001

All 2 as Felton International, Inc. →