Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart F — Obstetrical and Gynecological Therapeutic Devices](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices) → [21 CFR 884.5400](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5400) → HHE — Cup, Menstrual # HHE · Cup, Menstrual _Obstetrics/Gynecology · 21 CFR 884.5400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE ## Overview - **Product Code:** HHE - **Device Name:** Cup, Menstrual - **Regulation:** [21 CFR 884.5400](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/884.5400) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## Identification A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. ## Recent Cleared Devices (16 of 16) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233361](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K233361.md) | Sunny Cup and Applicator | Menstrual Mates | Jun 21, 2024 | SESE | | [K140626](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K140626.md) | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Meluna | Jul 10, 2014 | SESE | | [K121857](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K121857.md) | FEMMYCYCLE | Femcap Incorporated | Nov 15, 2012 | SESE | | [K120107](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K120107.md) | SCKOONCUP | Sckoon, Inc. | Sep 18, 2012 | SESE | | [K112165](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K112165.md) | RHEA CUP | Apex Medical Technologies, Inc. | May 24, 2012 | SESE | | [K092985](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K092985.md) | BELLECUP | Librette, Inc. | Jun 28, 2010 | SESE | | [K091754](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K091754.md) | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Lune Group , Ltd. | Nov 13, 2009 | SESE | | [K070965](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K070965.md) | ALICIA MENSTRUAL CUP | Alicia International Pty , Ltd. | Mar 5, 2008 | SESE | | [K060852](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K060852.md) | MOONCUP | Mooncup Limited | Dec 26, 2006 | SESE | | [K040335](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K040335.md) | MOONCUP, STYLE A & B | Mooncup, LLC | Mar 30, 2005 | SESE | | [K021356](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K021356.md) | THE DIVACUP MENSTRUAL SOLUTION | Diva International, Inc. | Jul 16, 2002 | SESE | | [K971303](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K971303.md) | INSTEAD, SOFTCUP | Ultrafem, Inc. | Jun 6, 1997 | SESE | | [K920792](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K920792.md) | SOFTCUP(TM):2 | Ultrafem, Inc. | Oct 5, 1993 | SESE | | [K910254](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K910254.md) | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | Apr 18, 1991 | SESD | | [K870803](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K870803.md) | THE KEEPER | The Keeper Co. | May 6, 1987 | SESE | | [K803250](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE/K803250.md) | TASSAWAY | Plastic Applications, Inc. | Feb 12, 1981 | SESE | ## Top Applicants - Ultrafem, Inc. — 2 clearances - Alicia International Pty , Ltd. — 1 clearance - Apex Medical Technologies, Inc. — 1 clearance - CooperSurgical, Inc. — 1 clearance - Diva International, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/HHE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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