FDA product code HEB: Tampon, Menstrual, Unscented
HEB is the FDA product code for tampon, menstrual, unscented. It is a Class II device, regulated under 21 CFR 884.5470 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 189 510(k) submissions under HEB, 17 in the last five years, from 61 different applicants. The average 510(k) review took 114 days (median 81); 185 days on average over the last three years. FDA has posted 36 recalls for HEB devices, 30 initiated in the last five years.
Definition
An unscented 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, Unscented |
| Device class | Class II |
| Regulation | 21 CFR 884.5470 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 122 |
| 2018 | 5 | 161 |
| 2019 | 7 | 219 |
| 2020 | 2 | 192 |
| 2021 | 6 | 66 |
| 2022 | 3 | 128 |
| 2023 | 5 | 126 |
| 2024 | 2 | 166 |
| 2025 | 6 | 122 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every HEB clearance
Top HEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tambrands, Inc. | 34 | 1996-08-13 |
| Personal Products Co. | 14 | 1999-08-31 |
| Kimberly-Clark Corp. | 12 | 2014-08-25 |
| First Quality Hygienic, Inc. | 8 | 2016-08-05 |
| Cotton High Tech S.L. | 7 | 2025-10-09 |
56 more applicants have HEB clearances. See the full list in Caduvo.
Most recent HEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252005 | Liviwell, Inc. | Livi Device | 2026-03-20 | 266 |
| K253719 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | 2025-12-17 | 23 |
| K252939 | Cotton High Tech S.L. | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | 2025-10-09 | 24 |
| K252613 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented menstrual three-piece applicator tampon | 2025-09-19 | 31 |
| K251033 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | 2025-08-13 | 132 |
Recalls for HEB devices
36 product recalls in 5 recall events; 30 initiated in the last five years and 30 still open. Most recent: 2025-12-26.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2025 | 30 |
Frequently asked questions
What is FDA product code HEB?
HEB is the FDA product code for tampon, menstrual, unscented. It is a Class II device, regulated under 21 CFR 884.5470 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEB?
Class II, regulation 21 CFR 884.5470. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEB?
Across 189 cleared submissions the average was 114 days from receipt to decision (median 81).
Which companies have the most HEB clearances?
Tambrands, Inc. (34); Personal Products Co. (14); Kimberly-Clark Corp. (12); First Quality Hygienic, Inc. (8); Cotton High Tech S.L. (7).
Have HEB devices been recalled?
Yes: 36 product recalls across 5 recall events; the most recent began 2025-12-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HEB
- Run a recall and safety report across every HEB manufacturer
- Watch product code HEB 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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