Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EME · 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) |
|---|---|---|---|---|---|
| K933670 | BIOPSY PUNCH, SURGICAL | Byron Medical | 1994-01-07 | 163 | 0 |
| K911285 | PULPDENT POLYAMIDE DENTIN LINER | Pulpdent Corp. | 1991-10-09 | 204 | 0 |
| K884740 | EURO-MED LIGHT TOUCH BIOPSY PUNCH | Buckman Co., Inc. | 1989-03-06 | 112 | 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