Tampax, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Tampax, Inc.” (first 1978, latest 1983), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 44 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 5 | 5 |
| HHD | Pad, Menstrual, Unscented | 3 | 3 |
| HHL | Pad, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 1 | 1 |
Review panels
Most recent Tampax, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832973 | TAMPAX SUPER DEODORANT MAXITHINS | HHL | 1983-11-28 | 88 |
| K832972 | REGULAR DEODORANT MAXITHINS PADS | HHL | 1983-11-28 | 88 |
| K832971 | DEODORANT MAXITHINS PANTY SHIELD | HHL | 1983-11-28 | 88 |
| K832974 | MAXITHINS UNSCENTED PANTY SHIELDS | HHD | 1983-10-14 | 43 |
| K821800 | REGULAR MAXITHINS PADS & SUPER MAXITHINS | HHD | 1982-06-25 | 18 |
| K820174 | TAMPAX TAMPONS | HEB | 1982-03-18 | 56 |
| K813642 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | HEB | 1982-01-25 | 26 |
| K810143 | TAMPAX DEODORANT TAMPONS | HIL | 1981-03-04 | 42 |
| K810160 | TAMPAX MAXITHINS PADS | HHD | 1981-01-28 | 6 |
| K802760 | PETAL SOFT PLASTIC APPLICATOR TAMPAX | HEB | 1981-01-12 | 68 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tampax, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tampax, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Tampax, Inc.” (first 1978, latest 1983), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tampax, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tampax, Inc. is 44 days.
Which FDA product codes appear under Tampax, Inc.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 5); HHD (Pad, Menstrual, Unscented, 3); HHL (Pad, Menstrual, Scented, Scented-Deodorized, 3).
Next steps
- See all 12 Tampax, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Tampax, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.