FDA product code HHD: Pad, Menstrual, Unscented
HHD is the FDA product code for pad, menstrual, unscented. It is a Class I device, regulated under 21 CFR 884.5435 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 136 510(k) submissions under HHD, from 51 different applicants. The average 510(k) review took 81 days (median 50).
Definition
An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Classification
| Field | Value |
|---|---|
| Device name | Pad, Menstrual, Unscented |
| Device class | Class I |
| Regulation | 21 CFR 884.5435 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HHD clearance
Top HHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kimberly-Clark Corp. | 13 | 1993-03-03 |
| Personal Products Co. | 12 | 1991-11-05 |
| Procter & Gamble Mfg. Co. | 11 | 1985-08-29 |
| Tambrands, Inc. | 10 | 1989-06-07 |
| Kao Corp. | 9 | 1989-08-11 |
46 more applicants have HHD clearances. See the full list in Caduvo.
Most recent HHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071827 | Procter & Gamble, Inc. | ALWAYS MENSTRUAL PADS | 2007-09-20 | 79 |
| K012629 | Procter & Gamble Co. | ALWAYS DUETS | 2001-10-05 | 53 |
| K003843 | Procter & Gamble Co. | ENVIVE MINIFORMS | 2001-02-08 | 58 |
| K993870 | Procter & Gamble Co. | UNSCENTED INTERLABIAL MENSTRUAL PAD | 2000-01-18 | 64 |
| K980395 | Keepers!, Inc. | GLADRAGS COTTON MENSTRUAL PAD | 1998-04-16 | 73 |
Recalls for HHD devices
openFDA lists no recalls for product code HHD.
Frequently asked questions
What is FDA product code HHD?
HHD is the FDA product code for pad, menstrual, unscented. It is a Class I device, regulated under 21 CFR 884.5435 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHD?
Class I, regulation 21 CFR 884.5435. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHD?
Across 136 cleared submissions the average was 81 days from receipt to decision (median 50).
Which companies have the most HHD clearances?
Kimberly-Clark Corp. (13); Personal Products Co. (12); Procter & Gamble Mfg. Co. (11); Tambrands, Inc. (10); Kao Corp. (9).
Next steps
- Run an FDA pathway report with predicate devices for product code HHD
- Run a recall and safety report across every HHD manufacturer
- Watch product code HHD 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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