Quick answer
FDA’s 510(k) database identifies K040335 as a record for MOONCUP, Style A and B. The entry lists the menstrual-cup device classification and a substantial-equivalence decision.
FDA record summary
| Record field | FDA entry |
|---|---|
| 510(k) number | K040335 |
| Device name | MOONCUP, Style A & B |
| Classification name | Cup, menstrual |
| Regulation number | 21 CFR 884.5400 |
| Product code | HHE |
| Decision date | March 30, 2005 |
| Decision | Substantially Equivalent (SESE) |
The record is specific to the device name and models shown. It should not be applied to every product using the word moon cup or to another menstrual-cup model.
Match a product to the record
- Compare the package and maker documentation with the FDA device name.
- Check the model and any size designation.
- Read the linked FDA entry and summary for the regulatory record.
- Keep product regulatory details separate from individual health decisions.
- Ask your doctor about symptoms or questions about menstrual products.
For a second product record, read the Lunette cup entry and the QuickScreen ovulation-test entry. Browse period products.
Related guides
- Lunette Menstrual Cup FDA 510(k) Record K091754
- QuickScreen Digital Ovulation Test: FDA Record CR260334
- Browse Cycle & period.
Sources
Common questions
What product does FDA K040335 name?
The record names MOONCUP, Style A and B, and classifies it as a menstrual cup.
What was the FDA decision date?
The database lists March 30, 2005, with a Substantially Equivalent decision.
Does the record tell me whether a cup is right for me?
No. It is a product regulatory entry. Ask your doctor about personal health questions.