# MVL: Cord, Retraction

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 264 days (middle half 204–287)
- 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)
- 2014: 2
- 2015: 2
- 2017: 4
- 2018: 1
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K050180: Expa-Syl (2005), cited by 7
- K123215: Viscostat Clear (2013), cited by 3
- K132526: Knit-Pak+ (2013), cited by 2
- K193389: Vista Clear (2020), cited by 2
- K083695: Traxodent (2009), cited by 2
- K093711: Racegel (2010), cited by 2
- K082116: Hemostasyl Paste (2008), cited by 2
- K171577: Smartcord, Smartcord X (2018), cited by 1
- K131799: Quicknit (2014), cited by 1
- K152064: Astringedent Clear (2015), cited by 1

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