Gateway Alloys, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Gateway Alloys, Inc.” (first 1996, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 22 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 27 | 27 |
| EJS | Alloy, Other Noble Metal | 4 | 4 |
Review panels
- Dental (31)
Most recent Gateway Alloys, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011661 | CONCORD 88 | EJT | 2001-08-27 | 90 |
| K011659 | GPW-SF | EJT | 2001-08-27 | 90 |
| K011628 | CONCORD 82 | EJT | 2001-07-16 | 48 |
| K011626 | CONCORD 72 | EJT | 2001-07-16 | 48 |
| K964950 | LA PLATA 28 (PM-28) | EJT | 1997-01-13 | 34 |
| K964949 | AURORA 53 | EJT | 1997-01-13 | 34 |
| K964948 | AURORA 52 (PM-01) | EJT | 1997-01-13 | 34 |
| K964941 | EL DORADO 40 | EJT | 1997-01-13 | 34 |
| K964940 | TAOS 28 | EJT | 1997-01-13 | 34 |
| K964838 | PALLADIA 85 (PM-13) | EJT | 1996-12-20 | 21 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Gateway Alloys, 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 Gateway Alloys, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Gateway Alloys, Inc.” (first 1996, latest 2001), 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 Gateway Alloys, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gateway Alloys, Inc. is 22 days.
Which FDA product codes appear under Gateway Alloys, Inc.?
The most frequent FDA product codes under this applicant name are EJT (Alloy, Gold-Based Noble Metal, 27); EJS (Alloy, Other Noble Metal, 4).
Next steps
- See all 31 Gateway Alloys, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJT, Gateway Alloys, 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.