510(k) Report

FDA applicant

Cardio Design Pty., Ltd.

Eden Prairie, MN2 decisions1996–19980 recalls

FDA records 2 decisions for Cardio Design Pty., Ltd. (Eden Prairie, MN) from 1996 to 1998: 2 510(k) clearances. 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 Cardio Design Pty., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Design Pty., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio Design Pty., 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?

  • HIRPerineometer2decisions

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.

  • K945611PeritronCardio Design Pty., Ltd. · 19961cites it
  • K983052Peritron Perineometer Model 9300V or 9300ACardio Design Pty., Ltd. · 19981cites it

What has FDA decided for it lately?

  • K983052Peritron Perineometer Model 9300V or 9300ACardio Design Pty., Ltd. · 1998
  • K945611PeritronCardio Design Pty., Ltd. · 1996

All 2 as Cardio Design Pty., Ltd. →