510(k) Report

FDA applicant

Kegelmaster 2000, Ltd.

Crofton, MD1 decision2002–20020 recalls

FDA records 1 decision for Kegelmaster 2000, Ltd. (Crofton, MD) in 2002: 1 510(k) clearance. All are in product code HIR (Perineometer). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Kegelmaster 2000, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kegelmaster 2000, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kegelmaster 2000, Ltd. 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?

  • HIRPerineometer1decision

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.

  • K023305Kegelmaster 2000Kegelmaster 2000, Ltd. · 20021cites it

What has FDA decided for it lately?

  • K023305Kegelmaster 2000Kegelmaster 2000, Ltd. · 2002

The one decision as Kegelmaster 2000, Ltd. →