FDA product code · Pathology
Somatic Gene Mutation Detection System
19 FDA decisions since 2011. 6 recalls name this code, 0 of them Class I.
The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OWD 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 · OWD
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWD
Too few OWD 510(k)s in any year since 2007 to give a median.
Recalls per year · OWD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWD
3in 2025
MAUDE reports naming product code OWD, 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 | 3 | — | 0 | 0 |
| 2012 | 4 | — | 1 | 0 |
| 2013 | 10 | — | 0 | 0 |
| 2014 | 6 | — | 1 | 2 |
| 2015 | 31 | — | 0 | 1 |
| 2016 | 21 | — | 0 | 1 |
| 2017 | 17 | — | 0 | 2 |
| 2018 | 36 | — | 0 | 0 |
| 2019 | 16 | — | 0 | 0 |
| 2020 | 15 | — | 1 | 3 |
| 2021 | 13 | — | 1 | 57 |
| 2022 | 12 | — | 2 | 53 |
| 2023 | 24 | — | 0 | 15 |
| 2024 | 9 | — | 0 | 5 |
| 2025 | 8 | — | 0 | 3 |
| 2026 | 9 | — | 0 | — |
Planning a device in OWD? 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