Product code HHE
- Device name
- Cup, Menstrual
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5400
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233361 | Sunny Cup and Applicator | Menstrual Mates | 2024-06-21 |
| K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Meluna | 2014-07-10 |
| K121857 | FEMMYCYCLE | Femcap Incorporated | 2012-11-15 |
| K120107 | SCKOONCUP | Sckoon, Inc. | 2012-09-18 |
| K112165 | RHEA CUP | Apex Medical Technologies, Inc. | 2012-05-24 |
| K092985 | BELLECUP | Librette, Inc. | 2010-06-28 |
| K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Lune Group , Ltd. | 2009-11-13 |
| K070965 | ALICIA MENSTRUAL CUP | Alicia International Pty , Ltd. | 2008-03-05 |
| K060852 | MOONCUP | Mooncup Limited | 2006-12-26 |
| K040335 | MOONCUP, STYLE A & B | Mooncup, LLC | 2005-03-30 |
| K021356 | THE DIVACUP MENSTRUAL SOLUTION | Diva International, Inc. | 2002-07-16 |
| K971303 | INSTEAD, SOFTCUP | Ultrafem, Inc. | 1997-06-06 |
| K920792 | SOFTCUP(TM):2 | Ultrafem, Inc. | 1993-10-05 |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | 1991-04-18 |
| K870803 | THE KEEPER | The Keeper Co. | 1987-05-06 |
| K803250 | TASSAWAY | Plastic Applications, Inc. | 1981-02-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00050428087701 | The DivaCup | Diva International Inc | 2026-03-31 |
| 00050428088852 | The DivaCup | Diva International Inc | 2026-03-31 |
| G391ANGPKSM2 | Angelcup - Pink | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G391ANGPKLG2 | Angelcup - Pink | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G391ANGLILSM2 | Angelcup - Lilac | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G391ANGLILLG2 | Angelcup - Lilac | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G391ANGCRSM2 | Angelcup - Crystal | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G391ANGCRLG2 | Angelcup - Crystal | Grupo IX Kaan, S.A. de C.V. | 2023-01-10 |
| G357DA0 | Kind Cup | Wevotopia LLC | 2022-11-28 |
| 20851906007006 | Softdisc | The Flex Company | 2022-09-29 |
| 09421906547023 | LORcup | X-HALTATION LIMITED | 2021-01-20 |
| 09421906547030 | LORcup | X-HALTATION LIMITED | 2021-01-20 |
| 08055349618074 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618067 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618050 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618043 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618036 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618005 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618029 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 08055349618012 | Mamicup® | MADALU' SRL | 2020-04-15 |
| 09421904034242 | Oi | ORGANIC INITIATIVE CORPORATION | 2020-04-02 |
| 09421904034266 | Oi | ORGANIC INITIATIVE CORPORATION | 2020-04-02 |
| 09421904034259 | Oi | ORGANIC INITIATIVE CORPORATION | 2020-04-02 |
| 37012713000486 | SUSTAIN NATURAL MENSTRUAL CUP | CLARIPHARM | 2018-10-19 |
| 37012713000493 | SUSTAIN NATURAL MENSTRUAL CUP | CLARIPHARM | 2018-10-19 |
| 00073010712485 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-10-01 |
| 00073010712492 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-10-01 |
| 00073010712508 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-10-01 |
| 00073010713253 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-10-01 |
| 00073010713260 | Tampax | PROCTER & GAMBLE MANUFACTURING COMPANY, THE | 2018-10-01 |