Brilliant Ray Intl., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Brilliant Ray Intl., Inc.” (first 1989, latest 1989), across 1 product code in 1 review panel. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Brilliant Ray Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892025 | PATIENT EXAM GLOVES (MFG. BEIJING LATEX FACTORY) | LYY | 1989-05-25 | 56 |
| K892024 | PATIENT EXAM GLOVES (MFG. CHAGAN TANG CAPITOL) | LYY | 1989-05-25 | 56 |
| K892023 | PATIENT EXAM GLOVES (MFG. XIAN WELFARE LATEX ) | LYY | 1989-05-25 | 56 |
| K892022 | PATIENT EXAM GLOVES (MFG. YU HUA LATEX FACTORY) | LYY | 1989-05-25 | 56 |
| K892109 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-04 | 31 |
| K891740 | PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO | LYY | 1989-04-14 | 23 |
| K891739 | PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY | LYY | 1989-04-14 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Brilliant Ray Intl., 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.
- Brilliant Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brilliant Ray Intl., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Brilliant Ray Intl., Inc.” (first 1989, latest 1989), 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 Brilliant Ray Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brilliant Ray Intl., Inc. is 56 days.
Which FDA product codes appear under Brilliant Ray Intl., Inc.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 7).
Next steps
- See all 7 Brilliant Ray Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Brilliant Ray Intl., 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.