# DRE: Dilator, Vessel, For Percutaneous Catheterization

- Device class: 2; regulation: 21 CFR 870.1310; FDA's rule: 510(k) required
- FDA decisions: 105
- 510(k) review time 2021–2025: median 30 days (middle half 29–135)
- Recalls: 16 (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: 2
- 2019: 3
- 2020: 3
- 2021: 1
- 2022: 3
- 2023: 2
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K070159: Prelude Sheath Introducer (2007), cited by 5
- K052557: Super Sheath Introducer Sheath (2006), cited by 5
- K070749: Estech Percutaneous Insertion Dilator Kit (2007), cited by 4
- K031691: Merit Mak (Mini Access Kit) (2003), cited by 4
- K081940: Avalon Elite Vascular Access Kit (2008), cited by 3
- K142546: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (2014), cited by 3
- K000737: Coaxial Dilator Set (2000), cited by 3
- K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0 (2006), cited by 3
- K140047: Lexiconture Mechanical Dilator Sheath Set (2014), cited by 3
- K902469: Byrd Dilator Sheath Set - Teflon (1990), cited by 3

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