FDA product code · Microbiology
Kit, Rna Detection, Human Papillomavirus
2 FDA decisions since 2011. No recall names this code.
For the detection of human papillomavirus RNA to aid in assessing risk of cancer.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OYB 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 · OYB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OYB
Too few OYB 510(k)s in any year since 2007 to give a median.
Recalls per year · OYB
No recall names OYB since 2007.
Adverse event reports per year · OYB
21in 2025
MAUDE reports naming product code OYB, 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 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 7 | — | 0 | 0 |
| 2016 | 6 | — | 0 | 1 |
| 2017 | 4 | — | 0 | 1 |
| 2018 | 12 | — | 0 | 2 |
| 2019 | 14 | — | 0 | 0 |
| 2020 | 9 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 3 | — | 0 | 1 |
| 2023 | 3 | — | 0 | 0 |
| 2024 | 4 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
Planning a device in OYB? 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