FDA product code · General hospital
Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
1 FDA decision since 2025. No recall names this code.
An ultraviolet light-based microbial reduction device for luer-activated valves is a device that uses ultraviolet light to irradiate luer-activated valves (e.g., as used for intravascular administration). The device is intended to supplement the manual, physical microbicidal treatment of luer-activated valves by providing limited microbial reduction, and is not intended to disinfect or replace manual microbicidal…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SGX 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 · SGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGX
Too few SGX 510(k)s in any year since 2007 to give a median.
Recalls per year · SGX
No recall names SGX since 2007.
Adverse event reports per year · SGX
No MAUDE report names SGX 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in SGX? 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