Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bergen Mfg. — 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) |
|---|---|---|---|---|---|
| K972299 | BERGEN MODEL 500 ELECTROSURGERY GENERATOR | Bergen Mfg. | 1997-08-27 | 69 | 0 |
| K964736 | BERGEN 610 BIPOLAR COAGULATOR | Bergen Mfg. | 1997-02-27 | 94 | 0 |
| K945861 | BERGEN 710 ESU | Bergen Mfg. | 1995-03-01 | 90 | 0 |
| K863701 | MODEL 709 BIPOLAR MICRO COAGULATOR | Bergen Mfg. | 1986-10-14 | 21 | 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