# EZL: Catheter, Retention Type, Balloon

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 131
- 510(k) review time 2021–2025: median 136 days (middle half 117–263)
- Recalls: 7 (2 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: 2
- 2018: 9
- 2019: 3
- 2020: 4
- 2021: 2
- 2022: 2
- 2023: 3
- 2024: 5
- 2025: 1
- 2026: 4

## Most-cited predicates
- K130908: Disposable Silicone Foley Catheter (2013), cited by 6
- K002868: Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard Lubri-Sil I.C. 3-Way Foley Catheter (2000), cited by 6
- K082815: Well Lead Silicone and Latex Foley Catheters (2008), cited by 6
- K984084: Bardex Lubri-Sil Foley Catheter (1999), cited by 4
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter (1998), cited by 4
- K980919: All Silicone 2-Way & 3-Way Foly Balloon Catheter and Nelaton Catheter (1998), cited by 3
- K042110: Beamcath (2005), cited by 3
- K003784: Mentor Self-Cath Plus (2001), cited by 3
- K961697: Opticon Female Urinary Incontinence Catheter for Continuous Drainage (1996), cited by 2
- K153655: Accuryn Monitoring System (2016), cited by 2

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