Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKL — 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) |
|---|---|---|---|---|---|
| K992582 | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | Pacific Implant, Inc. | 1999-10-21 | 80 | 0 |
| K961089 | PULPDENT ENDOPREP II | Pulpdent Corp. | 1996-04-23 | 35 | 0 |
| K822568 | EAR PROBES | Kelleher Corp. | 1982-09-14 | 21 | 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