Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OAH · 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) |
|---|---|---|---|---|---|
| K121991 | ENTEROCOCCUS QUICKFISH BC | Advandx, Inc. | 2013-01-07 | 185 | 0 |
| K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | Advandx, Inc. | 2009-07-24 | 282 | 1 |
| K082612 | GBS PNA FISH | Advandx, Inc. | 2009-05-05 | 238 | 0 |
| K063127 | ENTEROCOCCUS FAECALIS PNA FISH | Advandx, Inc. | 2006-12-22 | 70 | 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