FDA product code · Pathology
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
5 FDA decisions since 2014. No recall names this code.
The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PHP 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 · PHP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PHP
Too few PHP 510(k)s in any year since 2007 to give a median.
Recalls per year · PHP
No recall names PHP since 2007.
Adverse event reports per year · PHP
3in 2025
MAUDE reports naming product code PHP, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 5 | — | 0 | 1 |
| 2016 | 12 | — | 0 | 0 |
| 2017 | 7 | — | 0 | 1 |
| 2018 | 4 | — | 0 | 1 |
| 2019 | 13 | — | 0 | 3 |
| 2020 | 9 | — | 0 | 1 |
| 2021 | 6 | — | 0 | 5 |
| 2022 | 4 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 6 | — | 0 | 4 |
| 2025 | 16 | — | 0 | 3 |
| 2026 | 22 | — | 0 | — |
Planning a device in PHP? 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