Playtex Family Products, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Playtex Family Products, Inc.” (first 1989, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 15 | 15 |
| HEB | Tampon, Menstrual, Unscented | 2 | 2 |
Review panels
Most recent Playtex Family Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941196 | PLATEX TAMPONS MODEL NUMBER 07094 | HIL | 1994-04-19 | 36 |
| K940821 | PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED | HIL | 1994-03-25 | 31 |
| K936189 | PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED | HIL | 1994-03-07 | 70 |
| K935276 | PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS | HIL | 1994-03-07 | 124 |
| K934083 | PLAYTEX ULTIMATES TAMPONS | HIL | 1994-03-07 | 199 |
| K932909 | PLAYTEX ULTIMATES TAMPONS | HIL | 1994-03-07 | 264 |
| K932907 | PLAYTEX ULTIMATES TAMPONS | HIL | 1994-03-07 | 264 |
| K922834 | TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY | HIL | 1993-09-01 | 446 |
| K924279 | PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + | HIL | 1993-05-21 | 269 |
| K914438 | PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS | HIL | 1992-01-02 | 90 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Playtex Family Products, 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, Inc. (20 510(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 Family Products, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Playtex Family Products, Inc.” (first 1989, latest 1994), 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 Family Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Playtex Family Products, Inc. is 90 days.
Which FDA product codes appear under Playtex Family Products, Inc.?
The most frequent FDA product codes under this applicant name are HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 15); HEB (Tampon, Menstrual, Unscented, 2).
Next steps
- See all 17 Playtex Family Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIL, Playtex Family Products, 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.