Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Isolux, LLC — 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) |
|---|---|---|---|---|---|
| K163185 | OptiLux LED Illuminator | Isolux, LLC | 2016-11-21 | 7 | 0 |
| K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | Isolux, LLC | 2010-09-24 | 45 | 0 |
| K052979 | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | Isolux, LLC | 2005-10-31 | 7 | 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