Cleared Special

K010548 - MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010548 · Radionics, A Division of Tyco Healthcare Group LP · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
14d
Days
Class 2
Risk

K010548 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, A Division of Tyco Healthcare Group LP (Burlington, US). The FDA issued a Cleared decision on March 12, 2001 after a review of 14 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, A Division of Tyco Healthcare Group LP devices

Submission Details

510(k) Number K010548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date March 12, 2001
Days to Decision 14 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 148d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 422
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