Cleared Traditional

K231141 - STarFix Designer Software C0265 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231141 · FHC, Inc. · Neurology device
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Sep 2023
Decision
140d
Days
Class 2
Risk

K231141 is an FDA 510(k) clearance for the STarFix Designer Software C0265. Classified as Surgical Planning Software For Neurological Stereotaxic Instruments (product code QRI), Class II - Special Controls.

Submitted by FHC, Inc. (Bowdoin, US). The FDA issued a Cleared decision on September 8, 2023 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K231141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2023
Decision Date September 08, 2023
Days to Decision 140 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 148d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRI Surgical Planning Software For Neurological Stereotaxic Instruments
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition A Surgical Planning Software For Neurological Stereotaxic Instruments Is Intended As A Stand-alone Software Device Used For Pre- And Intra-operative Planning Of Stereotactic Or Image-guided Surgeries.
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.