Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Redwood Biotech, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
116 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000979 | REDI-SCREEN | Redwood Biotech, Inc. | 2000-04-10 | 14 | 0 |
| K993100 | REDI-SCREEN | Redwood Biotech, Inc. | 1999-10-06 | 20 | 0 |
| K991698 | REDI-TEST PCP | Redwood Biotech, Inc. | 1999-08-25 | 99 | 0 |
| K991110 | REDI-TEST COCAINE | Redwood Biotech, Inc. | 1999-07-26 | 116 | 0 |
| K991504 | REDI-TEST METHAMPHETAMINE | Redwood Biotech, Inc. | 1999-07-22 | 84 | 0 |
| K990870 | REDI-TEST THC | Redwood Biotech, Inc. | 1999-04-27 | 42 | 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