Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEW — 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) |
|---|---|---|---|---|---|
| K862635 | RABINOWITZ GUM MASSAGER | Arnell, Inc. | 1986-09-25 | 77 | 0 |
| K843406 | CHEW-DENT | Senair-Mot | 1984-12-11 | 102 | 0 |
| K790588 | ASSAY REAGENTS, LSA 290 | Kallestad Laboratories, Inc. | 1979-05-15 | 49 | 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