Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NZS · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093024 | YEAST TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2010-07-15 | 289 | 0 |
| K092784 | C. ALBICANS/C. GLABRATA PNA FISH | Advandx, Inc. | 2010-03-12 | 183 | 0 |
| K092655 | C. ALBICANS PNA FISH | Advandx, Inc. | 2010-01-19 | 144 | 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