FDA Product Code HHE: Cup, Menstrual
A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow.
Leading manufacturers include Meluna, Menstrual Mates and CooperSurgical, Inc..
16
Total
16
Cleared
216d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Cup, Menstrual Devices (Product Code HHE)
16 devices
Cleared
Jun 21, 2024
Sunny Cup and Applicator
Menstrual Mates
Obstetrics & Gynecology
266d
Cleared
Jul 10, 2014
MELUNA CLASSIC/SPORT MENSTRUAL CUP
Meluna
Obstetrics & Gynecology
121d
Cleared
Nov 15, 2012
FEMMYCYCLE
Femcap Incorporated
Obstetrics & Gynecology
142d
Cleared
Sep 18, 2012
SCKOONCUP
Sckoon, Inc.
Obstetrics & Gynecology
249d
Cleared
May 24, 2012
RHEA CUP
Apex Medical Technologies, Inc.
Obstetrics & Gynecology
301d
Cleared
Jun 28, 2010
BELLECUP
Librette, Inc.
Obstetrics & Gynecology
273d
Cleared
Nov 13, 2009
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
Lune Group , Ltd.
Obstetrics & Gynecology
150d
Cleared
Mar 05, 2008
ALICIA MENSTRUAL CUP
Alicia International Pty , Ltd.
Obstetrics & Gynecology
335d
Cleared
Dec 26, 2006
MOONCUP
Mooncup Limited
Obstetrics & Gynecology
273d
Cleared
Mar 30, 2005
MOONCUP, STYLE A & B
Mooncup, LLC
Obstetrics & Gynecology
413d
Cleared
Jul 16, 2002
THE DIVACUP MENSTRUAL SOLUTION
Diva International, Inc.
Obstetrics & Gynecology
78d
Cleared
Jun 06, 1997
INSTEAD, SOFTCUP
Ultrafem, Inc.
Obstetrics & Gynecology
59d
Cleared
Apr 18, 1991
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
CooperSurgical, Inc.
Obstetrics & Gynecology
86d
About Product Code HHE - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code HHE since 1981, with 16 receiving FDA clearance (average review time: 216 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.