Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FDG · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5 | Bioenterics Corp. | 1997-02-11 | 90 | 0 |
| K945421 | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | 1994-12-23 | 49 | 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