510(k) Report

FDA applicant

Arcon Corp.

Stewartville, MN2 decisions1984–19881 recall

FDA records 2 decisions for Arcon Corp. (Stewartville, MN) from 1984 to 1988: 2 510(k) clearances. All are in product code HIS (Condom). 1 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Arcon Corp. since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Arcon 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?

  • HISCondom2decisions

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.

  • K874383Mentor Plus (Condom)Arcon Corp. · 19881cites it

What has FDA decided for it lately?

  • K874383Mentor Plus (Condom)Arcon Corp. · 19881 recall
  • K841600CasablancaArcon Corp. · 1984

All 2 as Arcon Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K874383Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP…Dec 26, 2025Class II