Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
G.B.F. Industries, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
190 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862565 | CHEMTROL(TM) | G.B.F. Industries, Inc. | 1987-01-13 | 190 | 0 |
| K862586 | CHEMVARION(TM) | G.B.F. Industries, Inc. | 1986-08-04 | 28 | 0 |
| K862587 | CHEMTROL(TM) | G.B.F. Industries, Inc. | 1986-08-04 | 28 | 0 |
| K854850 | FALKON STRETCH-STERILE | G.B.F. Industries, Inc. | 1986-01-13 | 40 | 0 |
| K854432 | FALKON STRETCH | G.B.F. Industries, Inc. | 1985-11-22 | 17 | 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