Playtime Products, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Playtime Products, Inc.” (first 1993, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 77 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 | 3 | 3 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 2 | 2 |
Review panels
Most recent Playtime Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993794 | PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS | HEB | 2000-02-07 | 90 |
| K981760 | PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 | HEB | 1998-07-22 | 64 |
| K964269 | PLAYTEX TAMPONS GENTLE GLIDE DEORDORANT TAMPONS AND PLAYTEX/GENTLE GLIDE DEODORANT PORTABLES TAMPONS | HIL | 1996-11-29 | 35 |
| K961456 | PLAYTEX TAMPONS #10296 | HIL | 1996-06-18 | 63 |
| K952394 | PLAYTEX TAMPONS #13695 | HEB | 1995-08-21 | 91 |
| K950928 | ULTIMATES SILK GLIDE TAMPONS | HIL | 1995-03-22 | 21 |
| K923375 | PLAYSKOOL SUNGLASSES | HQY | 1993-06-09 | 335 |
| K923374 | VARIOUS SUNGLASSES | HQY | 1993-06-09 | 335 |
Recalls
openFDA lists no recalls under a recalling firm named Playtime 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Playtime Products, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Playtime Products, Inc.” (first 1993, latest 2000), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Playtime Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Playtime Products, Inc. is 77 days.
Which FDA product codes appear under Playtime Products, Inc.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 3); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 3); HQY (Sunglasses (Non-Prescription Including Photosensitive), 2).
Next steps
- See all 8 Playtime Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Playtime 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.