510(k) Report

FDA applicant

Ovusoft, LLC

Hampton, VA1 decision2001–20010 recalls

FDA records 1 decision for Ovusoft, LLC (Hampton, VA) in 2001: 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 Ovusoft, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ovusoft, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ovusoft, LLC 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 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.

  • K002726Tcoyf Fertility Software Version 1.0Ovusoft, LLC · 20011cites it

What has FDA decided for it lately?

  • K002726Tcoyf Fertility Software Version 1.0Ovusoft, LLC · 2001

The one decision as Ovusoft, LLC →