# MQR: Stent, Colonic, Metallic, Expandable

- Device class: 2; regulation: 21 CFR 878.3610; FDA's rule: 510(k) required
- FDA decisions: 16
- 510(k) review time 2021–2025: median 78 days (middle half 78–78)
- Recalls: 1 (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)
- 1999: 1
- 2000: 3
- 2003: 1
- 2004: 1
- 2006: 2
- 2012: 1
- 2018: 1
- 2019: 2
- 2020: 2
- 2024: 1

## Most-cited predicates
- K000281: Wallstent Enternal Prosthesis (2000), cited by 5
- K061877: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (2006), cited by 4
- K042065: Wallflex Enternal Colonic Stent and Anchor Lock Delivery System (2004), cited by 3
- K954290: Wallstent Enteral Endoprothesis (1996), cited by 2
- K030769: Ultraflex Precision Colonic Stent (2003), cited by 2
- K183616: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (2019), cited by 2
- K990034: Wilson-Cook Colonic Z-Stent (2000), cited by 1
- K113510: Evolution Colonic Stent System (2012), cited by 1
- K180180: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (2018), cited by 1
- K201159: WallFlex Colonic Stent System with Anchor Lock Delivery System (2020), cited by 1

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