Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KLP · 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) |
|---|---|---|---|---|---|
| K032279 | ONLINE TDM AMIKA | Roche Diagnostics Corp. | 2003-10-10 | 78 | 0 |
| K873426 | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 | Em Diagnostic Systems, Inc. | 1987-10-29 | 65 | 0 |
| K790899 | BACTEC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-05-23 | 14 | 0 |
| K780949 | BIO-MONITOR AMIKACIN | Monitor Science Corp. | 1978-08-14 | 66 | 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