Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avex Industries , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
558 daysmedian FDA review time
558 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935525 | PHOTOTHERAPEUTIX MODEL 2480AB | Avex Industries , Ltd. | 1995-05-19 | 549 | 0 |
| K933954 | PHOTOTHERAPEUTIX MODEL 2400B | Avex Industries , Ltd. | 1995-02-21 | 558 | 0 |
| K933953 | PHOTOTHERAPEUTIX MODEL 1650B | Avex Industries , Ltd. | 1995-02-21 | 558 | 0 |
| K933952 | PHOTOTHERAPEUTIX MODEL 800B | Avex Industries , Ltd. | 1995-02-21 | 558 | 0 |
| K935526 | PHOTOTHERAPEUTIX MODEL 1600B | Avex Industries , Ltd. | 1995-02-17 | 458 | 0 |
| K935524 | PHOTOTHERAPEUTIX MODEL 3200A | Avex Industries , Ltd. | 1995-02-17 | 458 | 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