Atlas FDA

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

Neurovirtual USA, Inc. · Predicate Candidate Screening

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

266 daysmedian FDA review time
782 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201495Maxxi Flow SensorNeurovirtual USA, Inc.2020-12-141920
K191492Maxxi Position SensorNeurovirtual USA, Inc.2020-04-243240
K191095Maxxi Snore SensorNeurovirtual USA, Inc.2020-01-162660
K171304Maxxi Rip SensorNeurovirtual USA, Inc.2019-06-247820
K163547MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold ElNeurovirtual USA, Inc.2017-04-111160
K131335BWMINI EEG, BWMINIHST, BWMINI PSGNeurovirtual USA, Inc.2015-02-036350
K112107BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUSNeurovirtual USA, Inc.2011-10-28980
K062533BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV Neurovirtual USA, Inc.2006-12-221150

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