Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Optical Frames, 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) |
|---|---|---|---|---|---|
| K970895 | CUSTOM OPTICAL SUNGLASS FRAMES | Custom Optical Frames, Inc. | 1997-05-06 | 56 | 0 |
| K962478 | (BRAND NAME) SUNGLASS FRAMES | Custom Optical Frames, Inc. | 1996-07-25 | 30 | 0 |
| K944373 | SPECTACLE FRAMES | Custom Optical Frames, Inc. | 1994-09-28 | 21 | 0 |
| K925224 | U108, U105, G209-B | Custom Optical Frames, Inc. | 1993-09-01 | 320 | 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