Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Biostar Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
103 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893896 | QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA | Biostar Medical Products, Inc. | 1989-07-14 | 45 | 0 |
| K893897 | SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM | Biostar Medical Products, Inc. | 1989-06-23 | 24 | 0 |
| K863238 | READS RF TEST KIT FOR IGM RHEUMATOID FACTOR | Biostar Medical Products, Inc. | 1986-10-08 | 48 | 0 |
| K861499 | BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1986-06-20 | 58 | 0 |
| K853697 | BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT | Biostar Medical Products, Inc. | 1985-12-16 | 103 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda