# KPN: Alarm, Conditioned Response Enuresis

- Device class: 2; regulation: 21 CFR 876.2040; FDA's rule: 510(k) exempt
- FDA decisions: 37
- Recalls: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1990: 4
- 1991: 1
- 1992: 1
- 1993: 2
- 1994: 2
- 1995: 2
- 1996: 3
- 1997: 1
- 1998: 1
- 2013: 1

## Most-cited predicates
- K844866: Nytone Enuretic Alarm Bedwetting Device (1985), cited by 1
- K955338: Drytime for Potty Training (1996), cited by 1
- K943559: Remote A'lert (1995), cited by 1

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