Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Max Endoscopy, Inc. — 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) |
|---|---|---|---|---|---|
| K083275 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE- | Max Endoscopy, Inc. | 2009-06-09 | 215 | 0 |
| K080764 | SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 | Max Endoscopy, Inc. | 2008-05-06 | 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