Not Cleared Direct

DEN220024 - ScanNav Anatomy Peripheral Nerve Block (FDA 510(k) Clearance)

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

DEN220024 · Intelligent Ultrasound Limited · Anesthesiology device
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Oct 2022
Decision
193d
Days
Class 2
Risk

DEN220024 is an FDA 510(k) submission (not cleared) for the ScanNav Anatomy Peripheral Nerve Block. Classified as Ultrasound Guided Nerve Block Assist (product code QRG), Class II - Special Controls.

Submitted by Intelligent Ultrasound Limited (Cardiff, GB). The FDA issued a Not Cleared (DENG) decision on October 18, 2022 after a review of 193 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Anesthesiology review framework.

View all Intelligent Ultrasound Limited devices

Submission Details

510(k) Number DEN220024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 08, 2022
Decision Date October 18, 2022
Days to Decision 193 days
Submission Type Direct
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 139d · This submission: 193d
Pathway characteristics

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.