FDA product code HHL: Pad, Menstrual, Scented, Scented-Deodorized
HHL is the FDA product code for pad, menstrual, scented, scented-deodorized. It is a Class II device, regulated under 21 CFR 884.5425 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 57 510(k) submissions under HHL, from 16 different applicants. The average 510(k) review took 51 days (median 45).
Definition
Scented or scented-deodorized menstrual pads used to absorb menstrual or other vaginal discharge, including those intended as intralabial pads or reusable menstrual pads. These are made with materials that do not meet the requirements for Class 1 per 21 CFR 884.5425(b).
Classification
| Field | Value |
|---|---|
| Device name | Pad, Menstrual, Scented, Scented-Deodorized |
| Device class | Class II |
| Regulation | 21 CFR 884.5425 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HHL clearance
Top HHL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tambrands, Inc. | 11 | 1989-06-07 |
| Procter & Gamble Mfg. Co. | 10 | 1987-01-21 |
| Kimberly-Clark Corp. | 7 | 1989-05-01 |
| Personal Products Co. | 6 | 1996-04-17 |
| Paragon Trade Brands, Inc. | 3 | 1996-10-10 |
11 more applicants have HHL clearances. See the full list in Caduvo.
Most recent HHL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962962 | Paragon Trade Brands, Inc. | DEODORANT PANTY LINER | 1996-10-10 | 72 |
| K962953 | Paragon Trade Brands, Inc. | DEODORANT PANTY SHIELD | 1996-10-10 | 72 |
| K962954 | Paragon Trade Brands, Inc. | DEODORANT MAXI PAD | 1996-10-10 | 72 |
| K961119 | Personal Products Co. | CAREFREE PANTYLINERS | 1996-04-17 | 27 |
| K913237 | Procter & Gamble Co. | ALWAYS, SCENTED/SCENTED DEODORIZED MENSTRUAL PAD | 1991-09-23 | 63 |
Recalls for HHL devices
openFDA lists no recalls for product code HHL.
Frequently asked questions
What is FDA product code HHL?
HHL is the FDA product code for pad, menstrual, scented, scented-deodorized. It is a Class II device, regulated under 21 CFR 884.5425 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHL?
Class II, regulation 21 CFR 884.5425. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHL?
Across 57 cleared submissions the average was 51 days from receipt to decision (median 45).
Which companies have the most HHL clearances?
Tambrands, Inc. (11); Procter & Gamble Mfg. Co. (10); Kimberly-Clark Corp. (7); Personal Products Co. (6); Paragon Trade Brands, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code HHL
- Run a recall and safety report across every HHL manufacturer
- Watch product code HHL 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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