# FMG: Stopcock, I.V. Set

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 272 days (middle half 242–447)
- Recalls: 82 (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)
- 2007: 2
- 2008: 2
- 2009: 2
- 2013: 2
- 2014: 1
- 2018: 1
- 2019: 2
- 2022: 2
- 2023: 2
- 2025: 1

## Most-cited predicates
- K022895: Elcam Stopcocks and Manifolds (2002), cited by 5
- K964435: Primary IV Set (1997), cited by 5
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock (2006), cited by 4
- K974083: Connecta Plus 1 and Connecta Plus 3 2-Way and 3-Way Stopcocks (1998), cited by 2
- K032393: Induction and Sampling Manifold (or Stopcock) (2003), cited by 2
- K053405: Bacstop (2006), cited by 2
- K962581: Stopcock Manifold Gangs (1996), cited by 2
- K862691: Stopcock (1986), cited by 1
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold (2013), cited by 1
- K911415: Trumpet Valve (1991), cited by 1

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