# MUM: Stent, Metallic, Expandable, Duodenal

- Device class: 2; regulation: 21 CFR 878.3610; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 145 days (middle half 86–205)
- 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)
- 1998: 1
- 2006: 1
- 2011: 1
- 2017: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K062750: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System, Models M00565010, M00565020, M00565030 (2006), cited by 4
- K101530: Evolution Duodenal Stent System, Model Evo-22-27-6-D, Evo-22-27-9-D, Evp-22-27-12-D (2011), cited by 2
- K980113: Wallstent Enteral Endoprosthesis (1998), cited by 2
- K163468: Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (2017), cited by 1
- K223067: Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent (2023), cited by 1

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