Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EAJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
86 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931269 | LEAD APRON | Bt Medical Co., Inc. | 1993-06-02 | 86 | 0 |
| K913621 | RINN PROTECTIVE X-RAY APRON AND PROTECTIVE COLLAR | Rinn Dental Products | 1991-09-27 | 45 | 0 |
| K870563 | X-RAY APRON | X-Tech, Ltd. | 1987-02-19 | 9 | 0 |
| K870103 | LEAD APRON CADDY | Orthopedic Systems, Inc. | 1987-01-21 | 12 | 0 |
| K832602 | THYROID PROTECTIVE COLLAR | E.M. Adams | 1983-09-29 | 58 | 0 |
| K832601 | LEADED X-RAY APRON | E.M. Adams | 1983-09-29 | 58 | 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