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

Advanced Brain Monitoring, Inc. · Predicate Candidate Screening

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

118 daysmedian FDA review time
197 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.2016-03-141100
K152040X8 System - Sleep Profiler (SP40), X8 System - Sleep ProfileAdvanced Brain Monitoring, Inc.2015-10-301000
K140190NIGHT SHIFTAdvanced Brain Monitoring, Inc.2014-05-291250
K131383X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH XAdvanced Brain Monitoring, Inc.2013-11-271970
K130007SLEEP PROFILERAdvanced Brain Monitoring, Inc.2013-04-171050
K130013X4 SYSTEMAdvanced Brain Monitoring, Inc.2013-01-31290
K120450SLEEP PROFILERAdvanced Brain Monitoring, Inc.2012-09-192180
K120447X4Advanced Brain Monitoring, Inc.2012-06-201270
K112514APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2012-01-091320
K111110APNEA GUARDAdvanced Brain Monitoring, Inc.2011-07-22930
K111194APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2011-07-07700
K110705APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2011-04-14310
K071230APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600Advanced Brain Monitoring, Inc.2007-10-031530
K041662APNEA RISK EVALUATION SYSTEM (ARES)Advanced Brain Monitoring, Inc.2004-10-141180

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