Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bonutti Research · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
89 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990156 | MULTITAK SS BUTTONS | Bonutti Research | 1999-03-05 | 45 | 0 |
| K973015 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-10-09 | 57 | 0 |
| K971144 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-06-25 | 89 | 0 |
| K964532 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-02-03 | 83 | 0 |
| K964324 | MULTITAK SS SUTURE SYSTEM | Bonutti Research | 1997-01-10 | 72 | 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