Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nordicneurolab — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

102 daysmedian FDA review time
208 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140956LCD MONITORNordicneurolab2014-08-071150
K133910NORDICBRAINEXNordicneurolab2014-04-041020
K123306NORDIC TUMOREXNordicneurolab2013-05-202080
K092253MODIFICATION TO FMRI HARDWARE SYSTEMNordicneurolab2009-10-08720
K080515FMRI HARDWARE SYSTEMNordicneurolab2008-05-16810
K073099FMRI HARDWARE SYSTEMNordicneurolab2007-11-20180

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