Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KJI · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
23 daysmedian FDA review time
76 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM | Miles Laboratories, Inc. | 1983-09-29 | 44 | 0 |
| K823370 | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | Syva Co. | 1982-12-03 | 23 | 0 |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | American Diagnostic Corp. | 1982-11-10 | 23 | 0 |
| K822808 | TDX KENAMYCIN | Abbott Laboratories | 1982-10-08 | 21 | 0 |
| K782125 | RIA KIT, KANAMYCIN | Diagnostic Products Corp. | 1979-01-10 | 14 | 0 |
| K772038 | KANAMYCIN RIA | Monitor Science Corp. | 1978-01-12 | 76 | 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