Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DZS · 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) |
|---|---|---|---|---|---|
| K822610 | PRECAPSULED DENTAL AMALGAM | Syntex Dental Products, Inc. | 1982-09-14 | 15 | 0 |
| K802967 | DISPERSALLOY-DISPERSED PHASE ALLOY SELF- | Johnson & Johnson Professionals, Inc. | 1980-12-30 | 39 | 0 |
| K781243 | MERCURY DISP. CAPSULE | Lee Pharmaceuticals | 1978-09-20 | 100 | 0 |
| K780966 | LEE-ALLOY DISPOSABLE CAPSULES | Lee Pharmaceuticals | 1978-08-21 | 70 | 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