Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DOG · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
29 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810477 | DCA DIGOX-SYN RIA TEST | Diagnostic Corp. of America | 1981-03-11 | 16 | 0 |
| K803045 | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | American Dade | 1980-12-22 | 21 | 0 |
| K781335 | DIGOXIN RIA (PEG) KIT | Ortho Diagnostics, Inc. | 1978-08-31 | 29 | 0 |
| K760709 | EMIT DIGOKIN ASSAY | Syva Co. | 1976-10-21 | 27 | 0 |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Dade, Baxter Travenol Diagnostics, Inc. | 1976-08-23 | 14 | 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