# EZD: Catheter, Straight

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 87
- 510(k) review time 2021–2025: median 205 days (middle half 139–273)
- Recalls: 3 (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)
- 2015: 1
- 2016: 3
- 2017: 2
- 2018: 3
- 2020: 1
- 2022: 10
- 2023: 6
- 2024: 5
- 2025: 6
- 2026: 11

## Most-cited predicates
- K100878: Self Cath Catheter (2010), cited by 8
- K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit (2007), cited by 3
- K973070: Conveen Easicath Set (1997), cited by 3
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated (2013), cited by 3
- K072539: Cure Catheter (2007), cited by 3
- K133615: Well Lead PVC Hydrophilic Urethral Catheter (2014), cited by 2
- K110653: Cure Catheter (2011), cited by 2
- K142575: Bard RiteCath Intermittent Urinary Catheter (2014), cited by 2
- K203637: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (2022), cited by 2
- K041464: Busse Hospital Disposables Urethral Catheter (2004), cited by 2

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