Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NXX · 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) |
|---|---|---|---|---|---|
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | Advandx, Inc. | 2012-04-03 | 139 | 1 |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | Advandx, Inc. | 2009-11-23 | 125 | 0 |
| K091827 | S. AUREUS PNA FISH | Advandx, Inc. | 2009-08-18 | 60 | 0 |
| K060099 | S. AUREUS PNA FISH | Advandx, Inc. | 2006-05-08 | 115 | 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