# DWP: Dilator, Vessel, Surgical

- Device class: 2; regulation: 21 CFR 870.4475; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 381 days (middle half 381–381)
- 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)
- 1989: 1
- 1990: 1
- 1991: 4
- 1996: 1
- 2003: 1
- 2010: 1
- 2013: 1
- 2017: 1
- 2019: 1
- 2023: 1

## Most-cited predicates
- K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators (2003), cited by 3
- K100518: Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 (2010), cited by 2
- K910682: Robicsek Probe/Retractor (1991), cited by 1
- K183438: Geomed Vascular Dilators (2019), cited by 1
- K792134: Bonchek-Shiley Vein Distention System (1979), cited by 1

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