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

Mri Interventions, Inc. — Predicate Candidate Screening

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

144 daysmedian FDA review time
268 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200079ClearPoint System and AccessoriesMri Interventions, Inc.2020-02-13300
K191701Arcus Head Fixation FrameMri Interventions, Inc.2019-11-151430
K191400Voyager Trajectory Array Guide (V-TAG)Mri Interventions, Inc.2019-06-21280
K181731MR Compatible Aspiration KitMri Interventions, Inc.2018-11-201440
K181195ClearPoint SystemMri Interventions, Inc.2018-11-021820
K171257ClearPoint SystemMri Interventions, Inc.2017-10-201750
K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.2016-03-26660
K160434ClearPoint SystemMri Interventions, Inc.2016-03-17300
K142505ClearPoint SystemMri Interventions, Inc.2015-10-214110
K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5Mri Interventions, Inc.2015-07-08300
K132436VARIOGUIDE DRILL KITMri Interventions, Inc.2014-03-202270
K123605SMARTFLOW CATHETERMri Interventions, Inc.2013-08-162680
K122456MRII CRAINIAL DRILLMri Interventions, Inc.2013-03-222210
K111802SV BRAIN ARRAY, SIEMENS 3TMri Interventions, Inc.2011-09-08730

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