# P130017: Cologuard

- Pathway: PMA
- Applicant: Exact Sciences Corporation
- Decided: Aug 11, 2014 after 430 days
- Product code: PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 28, 2017 · Class II · Z-2219-2017: Exact Sciences is correcting all Sample Mixer v2 Upgrade units because of incidents of Sample Mixer door damage, which has occurred when the Sample Holder opens during a run and the Sample Holder lid 

Source page: https://510kreport.com/device/P130017
Methodology: https://510kreport.com/methodology