PMA · Approved
ApprovedEuclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euclid Vision Corporation · NUU Lens, Contact, Orthokeratology, Overnight
Approved on Sep 29, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 100-day review.
- Decided
- Sep 29, 2004
- Review
- 100 days
- Class
- Class III
- Product code
- NUU
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040029 has 22 supplements since 2005: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2005 | 1 |
| 2016 | 2 |
| 2017 | 2 |
| 2019 | 4 |
| 2020 | 3 |
| 2021 | 4 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NUU devicesNUU Lens, Contact, Orthokeratology, Overnight: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/P040029 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040029: Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040029
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026