FDA product code · Ophthalmic
Lens, Contact, Orthokeratology, Overnight
5 FDA decisions since 2002. No recall names this code.
Temporary reduction of myopia or refractive error.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NUU 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 · NUU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUU
Too few NUU 510(k)s in any year since 2007 to give a median.
Recalls per year · NUU
No recall names NUU since 2007.
Adverse event reports per year · NUU
12in 2025
MAUDE reports naming product code NUU, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 7 | — | 0 | 6 |
| 2020 | 7 | — | 0 | 1 |
| 2021 | 5 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 3 | — | 0 | 5 |
| 2025 | 3 | — | 0 | 12 |
| 2026 | 5 | — | 0 | — |
Planning a device in NUU? 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 886.5916.