Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hach Company · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162471 | Hach CM130 Chlorine Monitoring System | Hach Company | 2017-03-30 | 205 | 0 |
| K070419 | OPACIDEN OPA REAGENT STRIPS | Hach Company | 2007-08-31 | 199 | 0 |
| K042322 | STERICHEK BLOOD LEAK REAGENT STRIPS | Hach Company | 2004-12-07 | 103 | 0 |
| K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | Hach Company | 2004-11-15 | 248 | 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