Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NQN — Predicate Candidate Screening
15 FDA 510(k) clearances under this product code; the 50 most recent screened below.
248 daysmedian FDA review time
449 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Applied Spectral Imaging , Ltd. | 2015-01-15 | 276 | 0 |
| K140465 | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINE | Ventana Medical Systems, Inc. | 2014-03-20 | 24 | 0 |
| K130515 | VIRTUOSO SYSTEM FOR IHC ER (SPI) | Ventana Medical Systems, Inc. | 2013-11-22 | 268 | 0 |
| K121516 | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | Ventana Medical Systems, Inc. | 2013-09-26 | 492 | 0 |
| K122143 | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | Ventana Medical Systems, Inc. | 2013-09-19 | 427 | 0 |
| K111872 | VIRTUOSO SYSTEM FOR IHC P53 (DO-7) | Ventana Medical Systems, Inc. | 2012-04-19 | 293 | 0 |
| K111869 | VIRTUOSO SYSTEM FOR IHC PR (IE2) | Ventana Medical Systems, Inc. | 2012-03-05 | 248 | 0 |
| K092333 | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 | Bioimagene, Inc. | 2010-10-27 | 449 | 0 |
| K073677 | SCANSCOPE XT SYSTEM | Aperio Technologies | 2008-08-01 | 217 | 0 |
| K061613 | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) | Tripath Imaging | 2007-01-10 | 215 | 1 |
| K062428 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS | Tripath Imaging, Inc. | 2006-09-29 | 42 | 0 |
| K053520 | VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 | Tripath Imaging, Inc. | 2006-04-11 | 113 | 0 |
| K050012 | VENTANA IMAGE ANALYSIS SYSTEM | Tripath Imaging, Inc. | 2005-05-06 | 123 | 0 |
| K033200 | ARIOL | Applied Imaging Corp. | 2004-03-18 | 168 | 0 |
| K031363 | QCA (VERSION 3.1) | Cell Analysis, Inc. | 2004-02-05 | 281 | 1 |
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