510(k) Report

FDA applicant

Lady Comp USA

Jeffersonville, IN1 decision2006–20060 recalls

FDA records 1 decision for Lady Comp USA (Jeffersonville, IN) in 2006: 1 510(k) clearance. 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 Lady Comp USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lady Comp USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lady Comp USA 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, Proceptive1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K050094Lady Comp UsaLady Comp USA · 20062cite it

What has FDA decided for it lately?

  • K050094Lady Comp UsaLady Comp USA · 2006

The one decision as Lady Comp USA →

Other applicant names beginning “Lady”

FDA records each applicant name separately; these may or may not be the same firm.

Lady'S Care, Inc. 2