Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEK · 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) |
|---|---|---|---|---|---|
| K990561 | OPTICAL FORCEPS | Pilling Weck Surgical | 1999-05-14 | 81 | 0 |
| K822198 | MALLEUS NIPPERS | Kelleher Corp. | 1982-08-25 | 33 | 0 |
| K822193 | FORCEPS FOR USE WITH RIGID ENDOSCOPES | Kelleher Corp. | 1982-08-24 | 32 | 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