Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pollux Endoscopy, Inc. — 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) |
|---|---|---|---|---|---|
| K002214 | SINUSCOPE AND BACCESSORIES | Pollux Endoscopy, Inc. | 2000-11-21 | 120 | 0 |
| K960872 | CYSTOSCOPE 0/15/30/70 DEGREES | Pollux Endoscopy, Inc. | 1996-05-07 | 64 | 0 |
| K953484 | POLLUX OA/POLLUX 30A/POLLUX 70A | Pollux Endoscopy, Inc. | 1995-09-01 | 38 | 0 |
| K943662 | LAPARASCOPE | Pollux Endoscopy, Inc. | 1995-05-25 | 301 | 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