PMA · Approved
Recalled · Class II · 2025ColoSense®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneoscopy, Inc. · SBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
Approved on May 3, 2024 through premarket approval, which rests on the device’s own clinical evidence after a 469-day review. It has been recalled once.
- Decided
- May 3, 2024
- Review
- 469 days
- Class
- Class III
- Product code
- SBB
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P230001 has 12 supplements since 2024: 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 |
|---|---|
| 2024 | 5 |
| 2025 | 5 |
| 2026 | 2 |
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 SBB? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2025 | Class II | Z-2077-2025 | Unknown/Undetermined by firm | Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All SBB devicesSBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 | — |
https://510kreport.com/device/P230001 · printed Nov 3, 2026
Cite this page
510(k) Report. “P230001: ColoSense®.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P230001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026