510(k) · Cleared
ClearedNerveblox
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Alfa Teknoloji San. Ve Tic. A.S. · QRG Ultrasound Guided Nerve Block Assist
Cleared on Aug 15, 2025 as substantially equivalent to K232787 (Intelligent Ultrasound Limited, 2023) after a 150-day review. Its family tree reaches back 2 generations to 2022.
- Decided
- Aug 15, 2025
- Review
- 150 days
- Class
- Class II
- Product code
- QRG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN220024 (2022). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRG device
- #1 K232787 ScanNav Anatomy Peripheral Nerve Blockscore 9.1 · 1 generation · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232787 | ScanNav Anatomy Peripheral Nerve BlockSummary page 6…Page 2/13 No 0038 Issue 2025 Revision 2025 No No: Device Trade Name: ScanNav Anatomy Peripheral Nerve Block Predicate #: K232787 Product code: QRG Device Description Summary: Nerveblox is a software as a medical device, designed to assist clinicians in ide… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All QRG devicesQRG Ultrasound Guided Nerve Block Assist: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QRG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRG
Too few QRG 510(k)s in any year since 2007 to give a median.
Recalls per year · QRG
No recall names QRG since 2007.
Adverse event reports per year · QRG
No MAUDE report names QRG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250818: Nerveblox.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250818
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026