FDA product code · Ophthalmic
Prosthesis, Eyelid Spacer/Graft, Polymer
FDA lists QWU as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 245 days (half between 245 and 245). 2 recalls name this code, 0 of them Class I.
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of QWU 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 · QWU
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWU
Too few QWU 510(k)s in any year since 2007 to give a median.
Recalls per year · QWU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QWU
6in 2025
MAUDE reports naming product code QWU, 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 | 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 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 2 | 6 |
| 2026 | 0 | — | 0 | — |
Planning a device in QWU? 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 886.3130.