# NEU: Marker, Radiographic, Implantable

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 110
- 510(k) review time 2021–2025: median 158 days (middle half 107–269)
- Recalls: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 8
- 2019: 5
- 2020: 3
- 2021: 3
- 2022: 2
- 2023: 4
- 2024: 10
- 2025: 5
- 2026: 1

## Most-cited predicates
- K063193: Modification to Biomarc Tissue Marker (2006), cited by 7
- K010348: Tantalum Beads - Radiographic Marker (2001), cited by 7
- K181007: Cianna Medical SAVI Scout Reflector and SAVI Scout System (2018), cited by 5
- K143484: BioZorb Marker (2015), cited by 5
- K060769: Hydromark Biopsy Site Marker (2006), cited by 5
- K093473: KMD-MARK1 Tissue Marker (2010), cited by 4
- K102506: Mixed Media Marker (2011), cited by 4
- K042296: Biomarc Preloaded Tissue Marker Device (2004), cited by 4
- K062528: Tissue Site Marking System (2007), cited by 4
- K093064: Tumark Professional, Model 271560, MR-Tumark Professional, Model 601560 (2010), cited by 4

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