Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DMP · 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) |
|---|---|---|---|---|---|
| K973973 | ELECSYS CALLCHECK DIGOXIN | Boehringer Mannheim Corp. | 1997-11-04 | 15 | 0 |
| K953393 | TOX PERFECT A TUBE | Chimera Research & Chemical, Inc. | 1995-10-06 | 84 | 0 |
| K780889 | DIGOXIN STANDARDS IN HUMAN SERUM | Pcl-Ria, Inc. | 1978-08-14 | 75 | 0 |
| K770411 | DIGI TROL TM-RX & DIGI TROL TM-TX | Nuclear Medical Laboratories, Inc. | 1977-03-16 | 12 | 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