Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advandx, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
289 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140619 | MECA XPRESSFISH | Advandx, Inc. | 2014-10-10 | 213 | 0 |
| K123418 | GRAM-NEGATIVE QUICKFISH BC | Advandx, Inc. | 2013-07-21 | 257 | 1 |
| K121991 | ENTEROCOCCUS QUICKFISH BC | Advandx, Inc. | 2013-01-07 | 185 | 0 |
| K113371 | STAPHYLOCOCCUS QUICKFISH BC | Advandx, Inc. | 2012-04-03 | 139 | 1 |
| K101558 | GNR TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2010-12-16 | 195 | 0 |
| 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 |
| K092236 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-12-16 | 146 | 1 |
| K092166 | S. AUREUS/CNS PNA FISH, MODEL KT005 | Advandx, Inc. | 2009-11-23 | 125 | 0 |
| K092393 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-09-01 | 27 | 1 |
| K091827 | S. AUREUS PNA FISH | Advandx, Inc. | 2009-08-18 | 60 | 0 |
| K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | Advandx, Inc. | 2009-07-24 | 282 | 1 |
| K082068 | E. COLI PNA FISH | Advandx, Inc. | 2009-06-25 | 338 | 0 |
| K082612 | GBS PNA FISH | Advandx, Inc. | 2009-05-05 | 238 | 0 |
| K081433 | EK/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2009-03-26 | 309 | 0 |
| K081309 | E.COLI/P. AERUGINOSA PNA FISH | Advandx, Inc. | 2008-12-19 | 224 | 0 |
| K080719 | YEAST TRAFFIC LIGHT PNA FISH | Advandx, Inc. | 2008-09-12 | 183 | 0 |
| K063127 | ENTEROCOCCUS FAECALIS PNA FISH | Advandx, Inc. | 2006-12-22 | 70 | 0 |
| K062461 | C. ALBICANS PNA FISH | Advandx, Inc. | 2006-10-25 | 63 | 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