Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fiber Imaging Technologies, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
77 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993300 | COLDLIGHTSOURCE PL3000 | Fiber Imaging Technologies, Inc. | 1999-11-05 | 35 | 0 |
| K992527 | URETERO-RENOSCOPE | Fiber Imaging Technologies, Inc. | 1999-10-13 | 77 | 0 |
| K992437 | SCHOELLY RIGID ENDOSCOPES | Fiber Imaging Technologies, Inc. | 1999-09-14 | 54 | 0 |
| K992040 | FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES | Fiber Imaging Technologies, Inc. | 1999-08-06 | 50 | 0 |
| K991560 | NASO-LARYNGO-PHARYNGOSCOPE | Fiber Imaging Technologies, Inc. | 1999-07-13 | 70 | 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