# K250818: Nerveblox

- Pathway: 510(k) (Traditional)
- Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.
- Decided: Aug 15, 2025 after 150 days
- Product code: QRG (Ultrasound Guided Nerve Block Assist)
- Device class: 2
- Regulation: 21 CFR 868.1980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN220024 (2022). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232787: ScanNav Anatomy Peripheral Nerve Block, Intelligent Ultrasound Limited (2023) Summary page 6.

## Indications for use
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)

Source page: https://510kreport.com/device/K250818
Methodology: https://510kreport.com/methodology