510(k) Report

FDA product code · Neurology

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

ORRClass II21 CFR 882.4560510(k) required4 decisions since 20100 recalls

4 FDA decisions since 2010. No recall names this code. The most-cited predicate is K181195, named by 2 later devices.

To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of ORR at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · ORR

1in 2018

2010: 12011: 12017: 12018: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ORR

Too few ORR 510(k)s in any year since 2007 to give a median.

Recalls per year · ORR

No recall names ORR since 2007.

Adverse event reports per year · ORR

1in 2022

2013: 22017: 12018: 22019: 12022: 1
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code ORR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—02
20140—00
20150—00
20160—00
20171—01
20181—02
20190—01
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — ORR by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ORR? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do ORR devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K181195ClearPoint SystemMri Interventions, Inc. · 20182cite it
  • K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 20111cites it
  • K100836Clearpoint SystemSurgivision, Inc. · 20101cites it
  • K171257ClearPoint SystemMri Interventions, Inc. · 20171cites it

Which ORR devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K181195ClearPoint SystemMri Interventions, Inc. · 20189generations
  • K171257ClearPoint SystemMri Interventions, Inc. · 20178generations
  • K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 20115generations
  • K100836Clearpoint SystemSurgivision, Inc. · 20104generations

What has FDA decided in ORR lately?

  • K181195ClearPoint SystemMri Interventions, Inc. · 2018
  • K171257ClearPoint SystemMri Interventions, Inc. · 2017
  • K111073Surgivision Inc. Clearpoint SystemSurgi-Vision, Inc. · 2011
  • K100836Clearpoint SystemSurgivision, Inc. · 2010

All 4 ORR decisions →

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