HHE · Cup, Menstrual
Obstetrics/Gynecology · 21 CFR 884.5400 · Class 2
Overview
| Product Code | HHE |
|---|---|
| Device Name | Cup, Menstrual |
| Regulation | 21 CFR 884.5400 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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 | Sunny Cup and Applicator | Menstrual Mates | Jun 21, 2024 | SESE |
| K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Meluna | Jul 10, 2014 | SESE |
| K121857 | FEMMYCYCLE | Femcap Incorporated | Nov 15, 2012 | SESE |
| K120107 | SCKOONCUP | Sckoon, Inc. | Sep 18, 2012 | SESE |
| K112165 | RHEA CUP | Apex Medical Technologies, Inc. | May 24, 2012 | SESE |
| K092985 | BELLECUP | Librette, Inc. | Jun 28, 2010 | SESE |
| K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Lune Group , Ltd. | Nov 13, 2009 | SESE |
| K070965 | ALICIA MENSTRUAL CUP | Alicia International Pty , Ltd. | Mar 5, 2008 | SESE |
| K060852 | MOONCUP | Mooncup Limited | Dec 26, 2006 | SESE |
| K040335 | MOONCUP, STYLE A & B | Mooncup, LLC | Mar 30, 2005 | SESE |
| K021356 | THE DIVACUP MENSTRUAL SOLUTION | Diva International, Inc. | Jul 16, 2002 | SESE |
| K971303 | INSTEAD, SOFTCUP | Ultrafem, Inc. | Jun 6, 1997 | SESE |
| K920792 | SOFTCUP(TM):2 | Ultrafem, Inc. | Oct 5, 1993 | SESE |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | Apr 18, 1991 | SESD |
| K870803 | THE KEEPER | The Keeper Co. | May 6, 1987 | SESE |
| K803250 | 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
