Cleared Traditional

K250818 - Nerveblox (FDA 510(k) Clearance)

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

K250818 · Smart Alfa Teknoloji San. Ve Tic. A.S. · Anesthesiology device
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Aug 2025
Decision
150d
Days
Class 2
Risk

K250818 is an FDA 510(k) clearance for the Nerveblox. Classified as Ultrasound Guided Nerve Block Assist (product code QRG), Class II - Special Controls.

Submitted by Smart Alfa Teknoloji San. Ve Tic. A.S. (Ankara, TR). The FDA issued a Cleared decision on August 15, 2025 after a review of 150 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1980 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K250818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2025
Decision Date August 15, 2025
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 139d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRG Ultrasound Guided Nerve Block Assist
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1980
Definition This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia.
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 Anesthesiology devices follow this clearance model.