FDA product code · Gastroenterology and urology
Light Source System, Diagnostic Endoscopic
1 FDA decision since 2010. No recall names this code.
A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OAY 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 · OAY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAY
Too few OAY 510(k)s in any year since 2007 to give a median.
Recalls per year · OAY
No recall names OAY since 2007.
Adverse event reports per year · OAY
3in 2025
MAUDE reports naming product code OAY, 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 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 1 |
| 2019 | 4 | — | 0 | 1 |
| 2020 | 6 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 3 | — | 0 | — |
Planning a device in OAY? 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