Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Driskell Bioengineering · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875242 | DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC | Driskell Bioengineering | 1988-02-26 | 66 | 0 |
| K875243 | DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC | Driskell Bioengineering | 1988-02-26 | 66 | 0 |
| K860982 | DB PRECISION IMPLANT SYSTEM, 2000 SERIES | Driskell Bioengineering | 1986-04-25 | 39 | 0 |
| K853788 | DB PRECISION IMPLANT SYSTEM | Driskell Bioengineering | 1985-10-31 | 51 | 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