Atlas FDA

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

Baxano, Inc. — Predicate Candidate Screening

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

132 daysmedian FDA review time
284 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113073IO-TOME DEVICEBaxano, Inc.2012-07-272840
K113533NEURO CHECK DEVICE WITH IO-FLEX WIREBaxano, Inc.2012-04-111330
K110696NEURO CHECK DEVICE WITH IO-FLEX WIREBaxano, Inc.2011-07-071150
K102594IO-FLEX CATHETERBaxano, Inc.2011-01-191320
K100958MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIESBaxano, Inc.2010-07-231070
K092729BAXANO NEURO CHECK DEVICEBaxano, Inc.2009-10-02280
K081742BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25Baxano, Inc.2008-09-17900
K080494BAXANO ULTRA LOW PROFILE RONGEURBaxano, Inc.2008-03-04110
K063231MICROBLADE SHAVER AND ACCESSORIESBaxano, Inc.2007-04-161730
K062711ULTRA LOW PROFILE RONGEURBaxano, Inc.2007-03-071770

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