De Novo · Granted
GrantedScanNav Anatomy Peripheral Nerve Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Ultrasound Limited · QRG Ultrasound Guided Nerve Block Assist
Granted on Oct 18, 2022 as a new device type through De Novo after a 193-day review. 2 later devices descend from it.
- Decided
- Oct 18, 2022
- Review
- 193 days
- Class
- Class II
- Product code
- QRG
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN220024 ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2022
- Descendant · cites it directly · 1 of its ownK232787 ScanNav Anatomy Peripheral Nerve BlockIntelligent Ultrasound Limited · 2023
- Descendant · 2 generations on · 0 of its ownK250818 NervebloxSmart Alfa Teknoloji San. Ve Tic. A.S. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220024 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | 2022 | — |
| +1 | K232787 | ScanNav Anatomy Peripheral Nerve Block | Intelligent Ultrasound Limited | 2023 | — |
| +2 | K250818 | Nerveblox | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 K250818 Nervebloxscore 10.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232787 | ScanNav Anatomy Peripheral Nerve Block | 2023 | 1 |
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?
- Of its descendants, K232787 (Intelligent Ultrasound Limited, 2023) has gone furthest, with 1 descendant of its own.
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. 2022, 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?
ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older. The highlighting of structures in the following anatomical regions is supported: • Axillary level brachial plexus • Erector spinae plane • Interscalene level…
Read the full statement (115 words)
ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.
The highlighting of structures in the following anatomical regions is supported:
• Axillary level brachial plexus
• Erector spinae plane
• Interscalene level brachial plexus
• Popliteal level sciatic nerve
• Rectus sheath plane
• Sub-sartorial femoral triangle / Adductor canal
• Superior trunk of brachial plexus
• Supraclavicular level brachial plexus
• Longitudinal suprainguinal fascia iliaca plane
ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220024 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220024: ScanNav Anatomy Peripheral Nerve Block.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220024
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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