Cleared Special

K001431 - MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

K001431 is an FDA 510(k) clearance for MODIFICATION TO OPTICAL TRACKING SYSTEM..., manufactured by Radionics, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 9-day FDA review.

K001431 · Radionics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
9d
Days
Class 2
Risk

K001431 is an FDA 510(k) clearance for the MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Radionics, Inc. devices

FDA 510(k) Submission Details - K001431

510(k) Number K001431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2000
Decision Date May 17, 2000
Days to Decision 9 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d faster than avg
Panel avg: 148d · This submission: 9d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 352
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K001431.
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · Stryker Corp. · Oct 2000
OPTICAL TRACKING SYSTEM (OTS)
K001950 · Radionics, Inc. · Jul 2000
SELF ADHERING NAVIGUS GUIDE
K001192 · Image-Guided Neurologics, Inc. · Jun 2000
SNN STEREOTAXIC PLANNING APPLICATION
K994421 · Surgical Navigation Specialists, Inc. · Feb 2000
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
K992461 · Surgical Navigation Technologies, Inc. · Feb 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · Philips Medical Systems (Cleveland), Inc. · Feb 2000