Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZB · 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) |
|---|---|---|---|---|---|
| K093737 | HEMOSIL F11 & FV DNA CONTROL | Instrumentation Laboratory CO | 2010-05-04 | 151 | 0 |
| K083171 | INTROL CF PANEL I CONTROL, MODEL: G106 | Maine Molecular Quality Controls, Inc. | 2008-12-16 | 50 | 0 |
| K063224 | GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL | Gentris Corporation | 2006-12-22 | 59 | 0 |
| DEN060007 | INTROL CF PANEL I CONTROL | Maine Molecular Quality Controls, Inc. | 2006-10-12 | 59 | 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