Playtex, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Playtex, Inc.” (first 1981, latest 2012), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 | 1 | 146 |
| 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 |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 13 | 13 |
| HEB | Tampon, Menstrual, Unscented | 7 | 7 |
Review panels
Most recent Playtex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120245 | PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS | HIL | 2012-06-21 | 146 |
| K980478 | PLAYTEX TAMPONS #03498 | HEB | 1998-04-03 | 56 |
| K971174 | PLAYTEX GENTLE GLIDE NATURAL ODOR ABSORBENT TAMPONS | HEB | 1997-05-21 | 51 |
| K944064 | PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894 | HEB | 1995-02-09 | 174 |
| K941044 | PLAYTEX ULTIMATED TAMPONS MODEL NUMBER 06194 | HIL | 1994-07-27 | 142 |
| K942418 | PLAYTEX TAMPONS MODEL 13794 | HEB | 1994-07-08 | 49 |
| K881057 | PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER | HIL | 1988-03-22 | 11 |
| K874509 | PLAYTEX NON & DEODORANT TAMPONS + PRIVATE LABEL | HIL | 1988-01-07 | 66 |
| K843551 | PLAYTEX BABY POWDER DEODORANT TAMPONS | HIL | 1984-12-03 | 84 |
| K841155 | DEODORANT SLENDER REG. TAMPONS | HIL | 1984-03-19 | 0 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Playtex, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Playtex Family Products, Inc. (17 510(k)s)
- Playtex Products, Inc. (17 510(k)s)
- Playtex Manufacturing, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Playtex, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Playtex, Inc.” (first 1981, latest 2012), across 2 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 Playtex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Playtex, Inc. is 54 days.
Which FDA product codes appear under Playtex, Inc.?
The most frequent FDA product codes under this applicant name are HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 13); HEB (Tampon, Menstrual, Unscented, 7).
Next steps
- See all 20 Playtex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIL, Playtex, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.