Atlas FDA

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

OLX — Predicate Candidate Screening

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

149 daysmedian FDA review time
462 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252565PreOp v3Clouds of Care2026-02-131830
K250239NeuroMatchLVIS Corporation2025-05-231160
K241513SourcererBrain Electrophysiology Laboratory Company, LLC2024-09-271210
K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY2024-05-151490
K210199RICOH MEGRicoh Company, Ltd.2021-07-021580
K201910EZTrackNeurologic, LLC2020-12-221660
K172858PreOpEpilog2018-01-081100
K092844GEOSOURCEElectrical Geodesics, Inc.2010-12-214620
K100126STELLATE GRIDVIEWExcel-Tech Ltd. (Xltek)2010-12-033180
K091393ELEKTA NEUROMAG WITH MAXFILTERElekta Neuromag OY2010-10-265330
K081430ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIElekta Neuromag OY2008-07-28680
K070358MAXINSIGHTEemagine Medical Imaging Solutions GmbH2007-07-301730
K050035ELEKTA NEUROMAG WITH MAXWELL FILTERElekta Neuromag OY2005-01-25180
K041264ELEKTA OYElekta Neuromag OY2004-08-10900
K040051MEGVISION, MODEL EQ1000C SERIESEagle Technology, Inc.2004-03-24720
K030737OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275Ctf Systems (2001), Inc.2003-10-102140
K011241NEUROSOFT'S SOURCENeurosoft, Inc.2001-09-191490
K001781CURRY MULTIMODAL NEUROIMAGING SOFTWARENeurosoft, Inc.2001-02-052370
K002631ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEGEemagine Medical Imaging Solutions GmbH2000-10-23610
K993708BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEGBiomagnetic Technologies, Inc.1999-12-03300
K984401NEUROMAG VECTORVIEWPhilips Medical Systems (Cleveland), Inc.1998-12-30210
K980477IMAGE VUE EEGSam Technology, Inc.1998-08-061810
K941553MAGNES II BIOMAGNETOMETERBiomagnetic Technologies, Inc.1996-05-167780
K901215700 SERIES BIOMAGNETOMETERBiomagnetic Technologies, Inc.1990-06-251030

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