Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKD · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851723 | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | Artiberia | 1985-07-02 | 68 | 0 |
| K821790 | BEACH EXCAVATOR'S NO. 1 & NO. 2 | Pacific Dental Corp. | 1982-07-06 | 19 | 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