FDA product code · Orthopedic
Intraoperative Surgical Angle Measurement Tool
3 FDA decisions since 2023. 510(k) reviews decided 2021–2025 took a median of 30 days (half between 29 and 30). No recall names this code. The most-cited predicate is DEN230012, named by 1 later device.
An intraoperative surgical angle measurement tool attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QWL 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 · QWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWL
Too few QWL 510(k)s in any year since 2007 to give a median.
Recalls per year · QWL
No recall names QWL since 2007.
Adverse event reports per year · QWL
No MAUDE report names QWL 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 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in QWL? 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