Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ja-Ru, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
202 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941682 | COOL KIDS BEADS AND SHADES | Ja-Ru, Inc. | 1994-05-17 | 42 | 0 |
| K935919 | SUNGLASSES | Ja-Ru, Inc. | 1994-02-16 | 70 | 0 |
| K934402 | COOL KIDS MIRROR SHADES | Ja-Ru, Inc. | 1994-01-25 | 138 | 0 |
| K935165 | BIKER MICE SUNGLASSES | Ja-Ru, Inc. | 1994-01-06 | 69 | 0 |
| K934852 | COOL KIDS HIP SHADES | Ja-Ru, Inc. | 1993-12-08 | 57 | 0 |
| K931389 | ITEM # 754 HOT FLIP SHADES | Ja-Ru, Inc. | 1993-10-06 | 202 | 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