510(k) Report

FDA applicant

Diva International, Inc.

Kitchener Ontario, CA1 decision2002–20020 recalls

FDA records 1 decision for Diva International, Inc. (Kitchener Ontario, CA) in 2002: 1 510(k) clearance. All are in product code HHE (Cup, Menstrual). 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 Diva International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Diva International, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diva International, 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?

  • HHECup, Menstrual1decision

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.

  • K021356The Divacup Menstrual SolutionDiva International, Inc. · 20022cite it

What has FDA decided for it lately?

  • K021356The Divacup Menstrual SolutionDiva International, Inc. · 2002

The one decision as Diva International, Inc. →

Other applicant names beginning “Diva”

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

Diva Medical Systems, Inc. 1