Cup, Menstrual
The Menstrual Cup is an intravaginal device made of flexible material, designed to be inserted into the vaginal canal to collect rather than absorb menstrual fluid, and can be emptied, cleaned, and reused. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty and is subject to premarket controls. The product code is HHE, regulated under 21 CFR 884.5400. No special risk flags apply.
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Basic Information
- Product Code
- HHE
- Device Class
- FDA class 2
- Regulation Number
- 884.5400
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233361 | Sunny Cup and Applicator | Jun 21, 2024 | Substantially Equivalent | Menstrual Mates |
| K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Jul 10, 2014 | Substantially Equivalent | Meluna |
| K121857 | FEMMYCYCLE | Nov 15, 2012 | Substantially Equivalent | Femcap Incorporated |
| K120107 | SCKOONCUP | Sep 18, 2012 | Substantially Equivalent | Sckoon, Inc. |
| K112165 | RHEA CUP | May 24, 2012 | Substantially Equivalent | Apex Medical Technologies, Inc. |
| K092985 | BELLECUP | Jun 28, 2010 | Substantially Equivalent | Librette, Inc. |
| K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Nov 13, 2009 | Substantially Equivalent | Lune Group , Ltd. |
| K070965 | ALICIA MENSTRUAL CUP | Mar 05, 2008 | Substantially Equivalent | Alicia International Pty , Ltd. |
| K060852 | MOONCUP | Dec 26, 2006 | Substantially Equivalent | Mooncup Limited |
| K040335 | MOONCUP, STYLE A & B | Mar 30, 2005 | Substantially Equivalent | Mooncup, LLC |
| K021356 | THE DIVACUP MENSTRUAL SOLUTION | Jul 16, 2002 | Substantially Equivalent | Diva International, Inc. |
| K971303 | INSTEAD, SOFTCUP | Jun 06, 1997 | Substantially Equivalent | Ultrafem, Inc. |
| K920792 | SOFTCUP(TM):2 | Oct 05, 1993 | Substantially Equivalent | Ultrafem, Inc. |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | Apr 18, 1991 | Unknown | CooperSurgical, Inc. |
| K870803 | THE KEEPER | May 06, 1987 | Substantially Equivalent | The Keeper Co. |
| K803250 | TASSAWAY | Feb 12, 1981 | Substantially Equivalent | Plastic Applications, Inc. |
FEI Numbers
This FDA classification entry is associated with 79 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 79 registration numbers. Click on an entry to view related FDA registrations.