PMA · Approved
Recalled · Class II · 2026FoundationOne CDx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foundation Medicine, Inc. · PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Approved on Nov 30, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 181-day review. It has been recalled 9 times.
- Decided
- Nov 30, 2017
- Review
- 181 days
- Class
- Class III
- Product code
- PQP
- Recalls
- 9
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P170019 has 61 supplements since 2018: 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 |
|---|---|
| 2018 | 2 |
| 2019 | 8 |
| 2020 | 8 |
| 2021 | 6 |
| 2022 | 8 |
| 2023 | 12 |
| 2024 | 8 |
| 2025 | 1 |
| 2026 | 8 |
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 PQP? 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 |
|---|---|---|---|---|
| Jun 10, 2026 | Class II | Z-2951-2026 | Software design | Software issue that can cause an increase in spontaneous software closures. |
| Mar 24, 2026 | Class II | Z-1937-2026 | Software change control | Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR. |
| Mar 20, 2026 | Class II | Z-1927-2026 | Under Investigation by firm | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants |
| Apr 9, 2025 | Class II | Z-1747-2025 | Under Investigation by firm | Four (4) total reports were sent to customers with clinically relevant variants requiring amendment, one (1) of which with an incorrect negative CDx claim. The remaining three (3) with tumor profiling result changes did not impact CDx… |
| Jun 18, 2024 | Class II | Z-1890-2025 | Software design | Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports. |
| Feb 15, 2023 | Class II | Z-1891-2025 | Software design | An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. |
| Nov 8, 2022 | Class II | Z-0577-2026 | Under Investigation by firm | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence. |
| Aug 8, 2019 | Class II | Z-0535-2020 | Under Investigation by firm | Identified potential false positive MSI-H on the test reports provided to the physicians. |
| Oct 31, 2018 | Class II | Z-0649-2019 | Other | An incorrect test result for a single analyte may have been reported for up to 800 physician reports |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PQP devicesPQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PQP
37so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PQP
Too few PQP 510(k)s in any year since 2007 to give a median.
Recalls per year · PQP
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQP
2in 2023
MAUDE reports naming product code PQP, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | — | 0 | 1 |
| 2018 | 15 | — | 1 | 1 |
| 2019 | 21 | — | 1 | 0 |
| 2020 | 25 | — | 0 | 1 |
| 2021 | 17 | — | 0 | 1 |
| 2022 | 33 | — | 2 | 1 |
| 2023 | 34 | — | 0 | 2 |
| 2024 | 34 | — | 0 | 0 |
| 2025 | 21 | — | 0 | 0 |
| 2026 | 37 | — | 3 | — |
https://510kreport.com/device/P170019 · printed Nov 6, 2026
Cite this page
510(k) Report. “P170019: FoundationOne CDx.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P170019
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026