510(k) Report

FDA applicant

Mri Interventions, Inc.

Irvine, CA14 decisions2011–20200 recalls

FDA records 14 decisions for Mri Interventions, Inc. (Irvine, CA) from 2011 to 2020: 14 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and HBG (Drills, Burrs, Trephines & Accessories (Manual)). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Mri Interventions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011: 12013: 22014: 12015: 22016: 22017: 12018: 22019: 22020: 1
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Mri Interventions, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mri Interventions, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument4decisions
  • HBGDrills, Burrs, Trephines & Accessories (Manual)3decisions
  • ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri2decisions
  • MOSCoil, Magnetic Resonance, Specialty1decision
  • HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)1decision
  • GWGEndoscope, Neurological1decision

Also: HCA (1), HBL (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 138 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122456Mrii Crainial DrillMri Interventions, Inc. · 20134cite it
  • K181195ClearPoint SystemMri Interventions, Inc. · 20182cite it
  • K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 20161cites it
  • K142505ClearPoint SystemMri Interventions, Inc. · 20151cites it
  • K160434ClearPoint SystemMri Interventions, Inc. · 20161cites it
  • K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 20151cites it

What has FDA decided for it lately?

  • K200079ClearPoint System and AccessoriesMri Interventions, Inc. · 2020
  • K191701Arcus Head Fixation FrameMri Interventions, Inc. · 2019
  • K191400Voyager Trajectory Array Guide (V-TAG)Mri Interventions, Inc. · 2019
  • K181731MR Compatible Aspiration KitMri Interventions, Inc. · 2018
  • K181195ClearPoint SystemMri Interventions, Inc. · 2018
  • K171257ClearPoint SystemMri Interventions, Inc. · 2017
  • K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
  • K160434ClearPoint SystemMri Interventions, Inc. · 2016

All 14 as Mri Interventions, Inc. →