510(k) Report

FDA applicant

Mooncup Limited

Brighton, GB2 decisions2005–20060 recalls

FDA records 2 decisions for Mooncup Limited (Brighton, GB) from 2005 to 2006: 2 510(k) clearances. All are in product code HHE (Cup, Menstrual). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mooncup, LLC”.

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 Mooncup Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mooncup Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mooncup Limited 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, Menstrual2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K040335Mooncup, Style a & BMooncup, LLC · 20053cite it
  • K060852MooncupMooncup Limited · 20061cites it

What has FDA decided for it lately?

  • K060852MooncupMooncup Limited · 2006
  • K040335Mooncup, Style a & BMooncup, LLC · 2005

The one decision as Mooncup Limited →The one decision as Mooncup, LLC →