Biostar Medical Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biostar Medical Products, Inc.” (first 1985, latest 1989), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| DAK | Complement C1q, Antigen, Antiserum, Control | 2 | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
Review panels
- Immunology (5)
Most recent Biostar Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893896 | QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA | LKJ | 1989-07-14 | 45 |
| K893897 | SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM | LKJ | 1989-06-23 | 24 |
| K863238 | READS RF TEST KIT FOR IGM RHEUMATOID FACTOR | DHR | 1986-10-08 | 48 |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | DAK | 1986-06-20 | 58 |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | DAK | 1985-12-16 | 103 |
Recalls
openFDA lists no recalls under a recalling firm named Biostar Medical 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.
- Biostar, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biostar Medical Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Biostar Medical Products, Inc.” (first 1985, latest 1989), across 3 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 Biostar Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biostar Medical Products, Inc. is 48 days.
Which FDA product codes appear under Biostar Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are DAK (Complement C1q, Antigen, Antiserum, Control, 2); LKJ (Antinuclear Antibody, Antigen, Control, 2); DHR (System, Test, Rheumatoid Factor, 1).
Next steps
- See all 5 Biostar Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DAK, Biostar Medical 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.