# KOE: Dilator, Urethral

- Device class: 2; regulation: 21 CFR 876.5520; FDA's rule: 510(k) exempt
- FDA decisions: 27
- 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)
- 1987: 2
- 1989: 2
- 1990: 4
- 1991: 1
- 1992: 3
- 1993: 1
- 1996: 2
- 1997: 1
- 2004: 1
- 2020: 1

## Most-cited predicates
- K961904: AQ Hydrophilic Dilators (1996), cited by 5
- K032840: Atrion Medical QL Inflation Device (2004), cited by 5
- K972964: Atrion Medical Balloon Catheter Inflation Device (1997), cited by 3
- K962611: Bard Eagle Inflation Device (1996), cited by 2
- K913477: Apex (TM) Prostatic Balloon Dilation Catheter (1991), cited by 1

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