Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fiberoptic Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
183 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944686 | FIBEROPTIC LARYNGOSCOPE HANDLE | Fiberoptic Medical Products, Inc. | 1994-11-04 | 42 | 0 |
| K933598 | ENDOSTAR(TM) STYLET | Fiberoptic Medical Products, Inc. | 1994-01-25 | 183 | 0 |
| K921393 | IMAGICA MICRO-ENDOSCOPE | Fiberoptic Medical Products, Inc. | 1992-08-20 | 150 | 0 |
| K912252 | INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT | Fiberoptic Medical Products, Inc. | 1991-06-27 | 37 | 0 |
| K883779 | WALLABY(TM) BLANKET | Fiberoptic Medical Products, Inc. | 1988-11-14 | 69 | 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