# OWE: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

- Device class: 2; regulation: 21 CFR 864.1890; FDA's rule: 510(k) required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2014: 4
- 2015: 1
- 2016: 3
- 2017: 2
- 2018: 3
- 2019: 2
- 2020: 2
- 2025: 1
- 2026: 1

## Most-cited predicates

Source page: https://510kreport.com/product-code/OWE
Data by year (CSV): https://510kreport.com/product-code/OWE.csv