FDA product code · Neurology
Non-Normalizing Quantitative Electroencephalograph Software
57 FDA decisions since 1981. 510(k) reviews decided 2021–2025 took a median of 175 days (half between 168 and 222). No recall names this code. The most-cited predicate is K080546, named by 5 later devices.
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OLT 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 · OLT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLT
266in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLT
No recall names OLT since 2007.
Adverse event reports per year · OLT
3in 2025
MAUDE reports naming product code OLT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | 266 | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | 217 | 0 | — |
Planning a device in OLT? 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) ReportRelated product codes
Other codes under 21 CFR 882.1400.