HHE
16 FDA 510(k) clearances · Product code
249 daysmedian time to decision
413 days90th percentile
16clearances measured
FDA profile
- Official device name
- Cup, Menstrual
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5400
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
- Adverse events (MAUDE)
- 2021: 40 · 2022: 26 · 2023: 133 · 2024: 29 · 2025: 35 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sunny Cup and Applicator (K233361) | Menstrual Mates | 2024-06-21 |
| MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626) | Meluna | 2014-07-10 |
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |
| SCKOONCUP (K120107) | Sckoon, Inc. | 2012-09-18 |
| RHEA CUP (K112165) | Apex Medical Technologies, Inc. | 2012-05-24 |
| BELLECUP (K092985) | Librette, Inc. | 2010-06-28 |
| LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754) | Lune Group , Ltd. | 2009-11-13 |
| ALICIA MENSTRUAL CUP (K070965) | Alicia International Pty , Ltd. | 2008-03-05 |
| MOONCUP (K060852) | Mooncup Limited | 2006-12-26 |
| MOONCUP, STYLE A & B (K040335) | Mooncup, LLC | 2005-03-30 |
| THE DIVACUP MENSTRUAL SOLUTION (K021356) | Diva International, Inc. | 2002-07-16 |
| INSTEAD, SOFTCUP (K971303) | Ultrafem, Inc. | 1997-06-06 |
| SOFTCUP(TM):2 (K920792) | Ultrafem, Inc. | 1993-10-05 |
| DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) (K910254) | CooperSurgical, Inc. | 1991-04-18 |
| THE KEEPER (K870803) | The Keeper Co. | 1987-05-06 |
| TASSAWAY (K803250) | Plastic Applications, Inc. | 1981-02-12 |
Track HHE automatically
Every clearance here is in the API, with alerts when new ones post.