Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NGZ — Predicate Candidate Screening

21 FDA 510(k) clearances under this product code; the 50 most recent screened below.

227 daysmedian FDA review time
326 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243738The Sensititre YeastOne Susceptibility System with MicafungiThermo Fisher Scientific2025-02-27850
K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)bioMerieux, Inc.2024-06-122650
K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)bioMerieux, Inc.2024-06-072600
K231433The Sensititre YeastOne Susceptibility System with RezafungiThermo Fisher Scientific2023-08-311060
K221198Sensititre YeastOne Susceptibility System with Fluconazole iThermo Fisher Scientific2023-03-103180
K221899The Sensititre YeastOne Susceptibility System with CaspofungThermo Fisher Scientific2023-01-202040
K211539Sensititre YeastOne Susceptibility System with Voriconazole Thermo Fisher Scientific2021-12-152110
K181368VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)bioMerieux, Inc.2018-06-20280
K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)bioMerieux, Inc.2016-03-252560
K151817VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLbioMerieux, Inc.2016-02-182270
K133952VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINEbioMerieux, Inc.2014-08-192390
K133817VITEK 2 AST - YEAST FLUCONAZOLEbioMerieux, Inc.2014-08-052320
K133038SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTrek Diagnostic Systems2014-01-311270
K101566VITEK 2 YEAST CASPOFUNGINbioMerieux, Inc.2010-09-281160
K092454VITEK 2 YEAST VORICONAZOLEbioMerieux, Inc.2010-05-212840
K082534ETEST VORICONAZOLE 0.002-32 UG/MLAb Biomerieux2009-11-024260
K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTrek Diagnostic Systems, Inc.2009-06-04591
K081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMITrek Diagnostic Systems, Inc.2009-03-063260
K061945VITEK 2 AST-YS FLUCONAZOLEbioMerieux, Inc.2006-09-19710
K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGAb Biodisk2004-07-271461
K991810MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TESTTrek Diagnostic Systems, Inc.2001-10-098660

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