FDA product code QRG: Ultrasound Guided Nerve Block Assist
QRG is the FDA product code for ultrasound guided nerve block assist. It is a Class II device, regulated under 21 CFR 868.1980 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under QRG, 2 in the last five years, from 2 different applicants. The average 510(k) review took 88 days (median 88); 150 days on average over the last three years. 1 De Novo request was granted under it.
Definition
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound Guided Nerve Block Assist |
| Device class | Class II |
| Regulation | 21 CFR 868.1980 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
510(k) clearances per year for QRG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 25 |
| 2025 | 1 | 150 |
Compare with all 510(k) review times · Search every QRG clearance
Top QRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smart Alfa Teknoloji San. Ve Tic. A.S. | 1 | 2025-08-15 |
| Intelligent Ultrasound Limited | 1 | 2023-10-06 |
Most recent QRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250818 | Smart Alfa Teknoloji San. Ve Tic. A.S. | Nerveblox | 2025-08-15 | 150 |
| K232787 | Intelligent Ultrasound Limited | ScanNav Anatomy Peripheral Nerve Block | 2023-10-06 | 25 |
Recalls for QRG devices
openFDA lists no recalls for product code QRG.
Frequently asked questions
What is FDA product code QRG?
QRG is the FDA product code for ultrasound guided nerve block assist. It is a Class II device, regulated under 21 CFR 868.1980 and reviewed by the Anesthesiology panel.
What device class is QRG?
Class II, regulation 21 CFR 868.1980. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRG?
Across 2 cleared submissions the average was 88 days from receipt to decision (median 88).
Which companies have the most QRG clearances?
Smart Alfa Teknoloji San. Ve Tic. A.S. (1); Intelligent Ultrasound Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRG
- Run a recall and safety report across every QRG manufacturer
- Watch product code QRG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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