Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isolux America · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022384 | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP | Isolux America | 2002-10-18 | 88 | 0 |
| K991572 | ISOLUX SURGICAL HEADLIGHT | Isolux America | 1999-07-08 | 64 | 0 |
| K991208 | ENDOSCOPIC FIBEROPTIC CABLE | Isolux America | 1999-06-23 | 75 | 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