Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Celon AG Medical Instruments · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073207 | OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB95 | Celon AG Medical Instruments | 2008-05-08 | 177 | 1 |
| K032838 | CELON ENT SYSTEM | Celon AG Medical Instruments | 2003-09-26 | 15 | 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