510(k) Report

FDA applicant

Bioself, Inc.

Thonex-Geneve-Suisse, CH3 decisions1983–19920 recalls

FDA records 3 decisions for Bioself, Inc. (Thonex-Geneve-Suisse, CH) from 1983 to 1992: 3 510(k) clearances. All are in product code LHD (Device, Fertility Diagnostic, Proceptive). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Bioself, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioself, 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?

  • LHDDevice, Fertility Diagnostic, Proceptive3decisions

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.

  • K904211Bioself 2000 Fertility IndicatorBioself, Inc. · 19921cites it

What has FDA decided for it lately?

  • K904211Bioself 2000 Fertility IndicatorBioself, Inc. · 1992
  • K843699Bioself TM 110Bioself, Inc. · 1984
  • K823209Bioself 101Bioself, Inc. · 1983

All 3 as Bioself, Inc. →