Quick answer
FDA’s database identifies K091754 as a record for LUNETTE MENSTRUAL CUP, Models 1 and 2. The entry lists the device classification and a substantial-equivalence decision.
FDA record summary
| Record field | FDA entry |
|---|---|
| 510(k) number | K091754 |
| Device name | LUNETTE MENSTRUAL CUP, Models 1 and 2 |
| Classification name | Cup, menstrual |
| Regulation number | 21 CFR 884.5400 |
| Product code | HHE |
| Decision date | November 13, 2009 |
| Decision | Substantially Equivalent (SESE) |
The entry identifies a specific device name and model pair. Read the record and the maker’s current product documentation together when identifying a product.
Product record checklist
- Compare the product name and model with the FDA entry.
- Confirm that the packaging uses the same brand and model identifiers.
- Read the linked FDA summary for the submitted device description.
- Do not treat a database match as a personal recommendation.
- Ask your doctor about menstrual-product questions or symptoms.
Compare Mooncup’s FDA entry and the QuickScreen at-home test record. Browse period products.
Related guides
- Mooncup FDA 510(k) Record K040335
- QuickScreen Digital Ovulation Test: FDA Record CR260334
- Browse Cycle & period.
Sources
Common questions
What product does FDA K091754 identify?
It names LUNETTE MENSTRUAL CUP, Models 1 and 2, and classifies it as a menstrual cup.
What is the product code?
The FDA record lists HHE.
Can the record answer a personal health question?
No. For personal questions about menstrual products or symptoms, speak with your doctor.