QRG · Class II · 21 CFR 868.1980

FDA Product Code QRG: Ultrasound Guided Nerve Block Assist

This Device Provides Real-time Interpretation And Enhanced Visualization Of Live Ultrasound Images By Highlighting Anatomical Landmarks In Preparation For Performing Regional Anesthesia.

Leading manufacturers include Intelligent Ultrasound Limited and Smart Alfa Teknoloji San. Ve Tic. A.S..

3
Total
2
Cleared
123d
Avg days
2022
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 150d recently vs 109d historically

FDA 510(k) Cleared Ultrasound Guided Nerve Block Assist Devices (Product Code QRG)

3 devices
1–3 of 3
Cleared Aug 15, 2025
Nerveblox
K250818
Smart Alfa Teknoloji San. Ve Tic. A.S.
Anesthesiology · 150d
Cleared Oct 06, 2023
ScanNav Anatomy Peripheral Nerve Block
K232787
Intelligent Ultrasound Limited
Anesthesiology · 25d
Not Cleared Oct 18, 2022
ScanNav Anatomy Peripheral Nerve Block
DEN220024
Intelligent Ultrasound Limited
Anesthesiology · 193d

About Product Code QRG - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QRG since 2022, with 2 receiving FDA clearance (average review time: 123 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA Review Time

Recent submissions under QRG have taken an average of 150 days to reach a decision - up from 109 days historically. Manufacturers should account for longer review timelines in current project planning.

QRG devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →