FDA product code · Anesthesiology
Ultrasound Guided Nerve Block Assist
3 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 88 days (half between 56 and 119). No recall names this code. The most-cited predicate is K232787, named by 1 later device.
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QRG at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in QRG? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report