# GBM: Catheter, Urethral

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 71
- 510(k) review time 2021–2025: median 262 days (middle half 262–263)
- Recalls: 16 (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)
- 2012: 3
- 2014: 1
- 2015: 5
- 2016: 3
- 2017: 2
- 2018: 6
- 2019: 7
- 2020: 6
- 2022: 2
- 2025: 1

## Most-cited predicates
- K023254: Speedicath (2003), cited by 7
- K050874: Astra Tech AB Lofric Primo Single Use Urinary Catheter (2005), cited by 6
- K072808: Speedicath Compact (2007), cited by 5
- K760093: Catheter, Silicone Foley (Bardex) (1976), cited by 4
- K141642: Vapro Intermittent Catheter (2014), cited by 4
- K190620: SpeediCath Flex Coude Pro (2019), cited by 3
- K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (2019), cited by 3
- K200134: Jimushi Sterile Urethral Catheter for single use (2020), cited by 3
- K181206: GentleCath Glide Intermittent Urinary Catheter (2018), cited by 3
- K180824: VaPro 2 Intermittent Catheter (2018), cited by 2

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