Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fiber Delivery Concepts, 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) |
|---|---|---|---|---|---|
| K904420 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Fiber Delivery Concepts, Inc. | 1991-04-08 | 193 | 0 |
| K904911 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM | Fiber Delivery Concepts, Inc. | 1991-01-25 | 86 | 0 |
| K904407 | DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG | Fiber Delivery Concepts, Inc. | 1990-12-18 | 83 | 0 |
| K896939 | DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG | Fiber Delivery Concepts, Inc. | 1990-03-08 | 85 | 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