FDA product code · Pathology
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
17 FDA decisions since 2016. 7 recalls name this code, 0 of them Class I.
A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PQP 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 · 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 | — |
Planning a device in PQP? 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