# FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 60
- 510(k) review time 2021–2025: median 149 days (middle half 111–186)
- Recalls: 39 (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)
- 1996: 7
- 1999: 1
- 2000: 1
- 2001: 3
- 2003: 2
- 2007: 2
- 2008: 1
- 2023: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K003873: Mentor Self-Cath Closed System (2001), cited by 6
- K010420: Rusch MMG/O'neil Catheter (2001), cited by 3
- K030712: Amsure Urethral Catheterization Tray (2003), cited by 2
- K963993: Rusch Simplastic Foley Catheterization Set (1996), cited by 2
- K910022: MMG/O'neil Urinary Catheterization System Kit (1991), cited by 2
- K910653: Touchless II Intermittent Catheter (1991), cited by 1
- K923538: Mon-a-Therm Foley Kit (1993), cited by 1

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