Nerveblox
FDA 510(k) K250818 · Smart Alfa Teknoloji San. Ve Tic. A.S.
510(k) numberK250818
Submission
- Device name
- Nerveblox
- Applicant
- Smart Alfa Teknoloji San. Ve Tic. A.S.
Ankara, TR - Received
- March 18, 2025
- Decision date
- August 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRG – Ultrasound Guided Nerve Block Assist
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1980
- Specialty
- Anesthesiology
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Other 510(k)s with product code QRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232787 | ScanNav Anatomy Peripheral Nerve BlockQRG · Special | Intelligent Ultrasound Limited | 10/06/2023SE |
More from Intelligent Ultrasound Limited
| 510(k) | Device | Decision |
|---|---|---|
| K260234 | MSK GoQIH · Traditional | 05/21/2026SE |
Questions and answers
When was Nerveblox cleared by the FDA?
Nerveblox (K250818) received a 510(k) decision of Substantially Equivalent on August 15, 2025, 150 days after the submission was received.
What is the product code of K250818?
The FDA product code is QRG – Ultrasound Guided Nerve Block Assist, a Class II (moderate risk) device regulated under 21 CFR 868.1980.