Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EIF · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940785 | MOUTH PROPS | Worldwide Dental, Inc. | 1994-10-05 | 225 | 0 |
| K873960 | LEWIS SAFE SLEEVE | Cheri Lewis, D.D.S. | 1987-12-04 | 67 | 0 |
| K830187 | FOCUS FLUID | Hematology Marketing Assoc. | 1983-03-01 | 41 | 0 |
| K830116 | SULCARINGS | North Pacific Dental, Inc. | 1983-02-18 | 38 | 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