# DXC: Clamp, Vascular

- Device class: 2; regulation: 21 CFR 870.4450; FDA's rule: 510(k) required
- FDA decisions: 205
- 510(k) review time 2021–2025: median 71 days (middle half 33–161)
- Recalls: 12 (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)
- 2017: 3
- 2018: 2
- 2019: 2
- 2020: 3
- 2021: 6
- 2022: 1
- 2023: 4
- 2024: 1
- 2025: 2
- 2026: 4

## Most-cited predicates
- K070423: TR Band (2007), cited by 11
- K024107: Femostop Femoral Compression System (2002), cited by 5
- K102025: Combat Ready Clamp (2010), cited by 5
- K915280: Femostop (1992), cited by 4
- K973080: Surgical Vascular Clamp (1998), cited by 4
- K974769: Cosgrove Clamp (1998), cited by 4
- K080206: Modification to Femostop Femoral Compression System (2008), cited by 3
- K092503: Radar Vascular Compression Devices (2009), cited by 3
- K040615: Compressar Supercomfort Disc and Strongarm Supercomfort System (2004), cited by 3
- K955132: Heartport Endoaortic Clamp (1996), cited by 3

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