Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kronus, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
590 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | 2023-08-24 | 590 | 0 |
| K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | Kronus, Inc. | 2018-11-23 | 261 | 0 |
| K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | 2018-01-19 | 221 | 0 |
| K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-07-22 | 7 | 0 |
| DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-04-25 | 298 | 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