Anesthesiology · 510(k) · 2025
Nerveblox
Smart Alfa Teknoloji San. Ve Tic. A.S.. Cleared by FDA on 15 August 2025 under submission K250818, product code QRG (ultrasound guided nerve block assist). What FDA's record says, in FDA's words.
Device record · K250818
- Device. NervebloxDEVICE
- Company. Smart Alfa Teknoloji San. Ve Tic. A.S. (TR)COMPANY
- Decision. 15 August 2025, 510(k), substantially equivalent (traditional review); received 18 March 2025DECISION
- Panel. AnesthesiologyPANEL
- Product code. QRG, Ultrasound Guided Nerve Block AssistCODE
- Regulation. 21 CFR 868.1980, Class IIREG
- Source. FDA database entry · decision document (17 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Nerveblox assists qualified healthcare professionals in identifying anatomical structures in the following ultrasound- guided peripheral nerve block regions for use prior to any needle intervention and is used for adult patients 18 years of age or older. It is not used in combination with needles or during needle insertion. Nerveblox supports users in the following block regions: • Interscalene Brachial Plexus • Supraclavicular Brachial Plexus • Infraclavicular Brachial Plexus • Cervical Plexus • Axillary Brachial Plexus • PECS I & II • Transversus Abdominis Plane (TAP) • Rectus Sheath • Femoral Nerve • Adductor Canal • Popliteal Sciatic • Erector Spinae Plane (ESP)
The product code's definition, from FDA's classification record. This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedultrasound
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QRG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QRG, in Anesthesiology, from Smart Alfa Teknoloji San. Ve Tic. A.S., or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.