Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Designs For Vision, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
45 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051786 | MELIDE FIBEROPTIC LIGHT | Designs For Vision, Inc. | 2005-08-15 | 45 | 0 |
| K043530 | DVI CURING LIGHT | Designs For Vision, Inc. | 2005-01-25 | 35 | 0 |
| K032283 | DESIGNS FOR VISION FIBEROPTIC LIGHT | Designs For Vision, Inc. | 2003-08-20 | 27 | 0 |
| K013880 | DAYLITE XENON LIGHT SOURCES | Designs For Vision, Inc. | 2001-12-07 | 14 | 0 |
| K801058 | ILLUMINATED SPECULUM | Designs For Vision, Inc. | 1980-05-28 | 22 | 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