# KNY: Accessories, Catheter, G-U

- Device class: 2; regulation: 21 CFR 876.5130; FDA's rule: 510(k) required
- FDA decisions: 65
- Recalls: 2 (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)
- 2005: 3
- 2006: 3
- 2009: 1
- 2011: 1
- 2012: 1
- 2013: 2
- 2014: 3
- 2017: 1
- 2018: 1
- 2026: 1

## Most-cited predicates
- K981611: Snap-N-Peel Introducers (1998), cited by 2
- K042531: Updated Slip Urology Introducer Sheath (2005), cited by 2
- K000767: Memcath Urology Introducer Sheath, Model 201 (2000), cited by 2
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), cited by 2
- K900031: Modified Pediatric Silicone Foley Catheters (1990), cited by 1
- K141252: Guardian Urethral Sheath (2014), cited by 1
- K942074: Flexfinder Guidewire (1994), cited by 1
- K120160: Rocamed Rocaus Platinum (2012), cited by 1
- K123170: Vari-Pass Variable Length Access Sheath (2013), cited by 1
- K952414: Prefilled Syringe for Inflation of Foley Catheter (1995), cited by 1

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