FDA product code · Immunology
P2psa
1 FDA decision since 2012. No recall names this code.
Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OYA 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 · OYA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OYA
Too few OYA 510(k)s in any year since 2007 to give a median.
Recalls per year · OYA
No recall names OYA since 2007.
Adverse event reports per year · OYA
1in 2023
MAUDE reports naming product code OYA, 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 | 2 | — | 0 | 0 |
| 2013 | 6 | — | 0 | 0 |
| 2014 | 4 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | — | 0 | 0 |
| 2020 | 4 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in OYA? 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