FDA product code HIL: Tampon, Menstrual, Scented, Scented-Deodorized
HIL is the FDA product code for tampon, menstrual, scented, scented-deodorized. It is a Class II device, regulated under 21 CFR 884.5460 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 84 510(k) submissions under HIL, from 15 different applicants. The average 510(k) review took 67 days (median 46).
Definition
A scented or scented-deodorized menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.
Classification
| Field | Value |
|---|---|
| Device name | Tampon, Menstrual, Scented, Scented-Deodorized |
| Device class | Class II |
| Regulation | 21 CFR 884.5460 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HIL clearance
Top HIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Playtex Family Products, Inc. | 15 | 1994-04-19 |
| Playtex, Inc. | 13 | 2012-06-21 |
| Tambrands, Inc. | 13 | 1995-07-28 |
| Playtex Products, Inc. | 11 | 2008-01-17 |
| Personal Products Co. | 6 | 1995-10-20 |
10 more applicants have HIL clearances. See the full list in Caduvo.
Most recent HIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132208 | Ontex Bvba | ONTEX AND OTHERS PROPRIETARY NAMES | 2014-04-10 | 268 |
| K132819 | Playtex Manufacturing, Inc. | PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS | 2013-10-09 | 30 |
| K120245 | Playtex, Inc. | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | 2012-06-21 | 146 |
| K111684 | Playtex Manufacturing, Inc. | PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD | 2012-02-03 | 233 |
| K081555 | Procter & Gamble Co. | TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED | 2008-06-27 | 24 |
Recalls for HIL devices
openFDA lists no recalls for product code HIL.
Frequently asked questions
What is FDA product code HIL?
HIL is the FDA product code for tampon, menstrual, scented, scented-deodorized. It is a Class II device, regulated under 21 CFR 884.5460 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIL?
Class II, regulation 21 CFR 884.5460. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIL?
Across 84 cleared submissions the average was 67 days from receipt to decision (median 46).
Which companies have the most HIL clearances?
Playtex Family Products, Inc. (15); Playtex, Inc. (13); Tambrands, Inc. (13); Playtex Products, Inc. (11); Personal Products Co. (6).
Next steps
- Run an FDA pathway report with predicate devices for product code HIL
- Run a recall and safety report across every HIL manufacturer
- Watch product code HIL 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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