FDA product code HHE: Cup, Menstrual
HHE is the FDA product code for cup, menstrual. It is a Class II device, regulated under 21 CFR 884.5400 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 16 510(k) submissions under HHE, 1 in the last five years, from 15 different applicants. The average 510(k) review took 216 days (median 200); 266 days on average over the last three years.
Definition
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Classification
| Field | Value |
|---|---|
| Device name | Cup, Menstrual |
| Device class | Class II |
| Regulation | 21 CFR 884.5400 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for HHE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 266 |
Compare with all 510(k) review times · Search every HHE clearance
Top HHE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ultrafem, Inc. | 2 | 1997-06-06 |
| Menstrual Mates | 1 | 2024-06-21 |
| Meluna | 1 | 2014-07-10 |
| Femcap Incorporated | 1 | 2012-11-15 |
| Sckoon, Inc. | 1 | 2012-09-18 |
10 more applicants have HHE clearances. See the full list in Caduvo.
Most recent HHE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233361 | Menstrual Mates | Sunny Cup and Applicator | 2024-06-21 | 266 |
| K140626 | Meluna | MELUNA CLASSIC/SPORT MENSTRUAL CUP | 2014-07-10 | 121 |
| K121857 | Femcap Incorporated | FEMMYCYCLE | 2012-11-15 | 142 |
| K120107 | Sckoon, Inc. | SCKOONCUP | 2012-09-18 | 249 |
| K112165 | Apex Medical Technologies, Inc. | RHEA CUP | 2012-05-24 | 301 |
Recalls for HHE devices
openFDA lists no recalls for product code HHE.
Frequently asked questions
What is FDA product code HHE?
HHE is the FDA product code for cup, menstrual. It is a Class II device, regulated under 21 CFR 884.5400 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHE?
Class II, regulation 21 CFR 884.5400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHE?
Across 16 cleared submissions the average was 216 days from receipt to decision (median 200).
Which companies have the most HHE clearances?
Ultrafem, Inc. (2); Menstrual Mates (1); Meluna (1); Femcap Incorporated (1); Sckoon, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HHE
- Run a recall and safety report across every HHE manufacturer
- Watch product code HHE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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