Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DNL — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
65 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852343 | DIG RADIOIMMUNOASSAY TEST SYSTEM | M Nobird, Inc. | 1985-07-09 | 36 | 0 |
| K852291 | TIPSEP DIGOXIN RIA | Nuclear Diagnostics, Inc. | 1985-06-25 | 27 | 0 |
| K811212 | DIGOXIN (RIA) KIT | Immuno Assay Corp. | 1981-05-21 | 17 | 0 |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | 1981-04-21 | 13 | 0 |
| K802841 | DIGOXIN RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | 1980-12-18 | 36 | 0 |
| K781834 | TEST SET, 125 I-DIGOXIN | Wien Laboratories, Inc. | 1979-01-03 | 65 | 0 |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | New England Nuclear | 1978-09-14 | 15 | 0 |
| K772110 | IN VITRO DIGOXIN RIA TEST | Clinical Assays, Inc. | 1977-11-22 | 15 | 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