U.S. Toy Co., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “U.S. Toy Co., Inc.” (first 1993, latest 1993), across 1 product code in 1 review panel. Median 510(k) review time under this name: 81 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 |
|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent U.S. Toy Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934309 | DISCO SUNGLASSES NONPRESCRIPTION SUNGLASSES | HQY | 1993-11-02 | 81 |
| K934308 | CHILD NONPRESCRIPTION SUNGLASSES | HQY | 1993-11-02 | 81 |
| K934307 | BUTTERFLY NONPRESCRIPTION SUNGLASSES | HQY | 1993-11-02 | 81 |
| K934305 | AVIATOR NONPRESCRIPTION SUNGLASSES | HQY | 1993-11-02 | 81 |
| K934304 | ANIMAL NONPRESCRIPTION SUNGLASSES | HQY | 1993-11-02 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named U.S. Toy Co., 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 U.S. Toy Co., Inc.?
FDA lists 5 510(k) clearances under the applicant name “U.S. Toy Co., Inc.” (first 1993, latest 1993), across 1 product code 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 U.S. Toy Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Toy Co., Inc. is 81 days.
Which FDA product codes appear under U.S. Toy Co., Inc.?
The most frequent FDA product codes under this applicant name are HQY (Sunglasses (Non-Prescription Including Photosensitive), 5).
Next steps
- See all 5 U.S. Toy Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQY, U.S. Toy Co., 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.