Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DDE · 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) |
|---|---|---|---|---|---|
| K902055 | TENONE(TM) OPIATES CATALOG: VKSO1,4 | Diagnostic Products Corp. | 1990-07-10 | 64 | 0 |
| K823680 | COAT-A-COUNT MORPHINE KIT & COMPONENTS | Diagnostic Products Corp. | 1983-01-05 | 29 | 0 |
| K820900 | EMIT URINE METHADONE ASSAY #3E319 | Syva Co. | 1982-04-26 | 26 | 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