Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EBE · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832500 | CS-11 | Chema-Scutum, Inc. | 1983-10-27 | 92 | 0 |
| K830491 | JOHNSON & JOHNSON OPAQUE COLOR MODIFI | Johnson & Johnson Professionals, Inc. | 1983-03-17 | 30 | 0 |
| K790339 | CONCEPT II | Richardson Merrel, Inc. | 1979-07-17 | 146 | 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