FDA product code · Pathology
System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
1 FDA decision since 2024. No recall names this code.
The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SBB 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 · SBB
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SBB
Too few SBB 510(k)s in any year since 2007 to give a median.
Recalls per year · SBB
No recall names SBB since 2007.
Adverse event reports per year · SBB
No MAUDE report names SBB since 2007.
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 | 0 | — | 0 | 0 |
| 2024 | 6 | — | 0 | 0 |
| 2025 | 5 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
Planning a device in SBB? 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