# KKO: Ring, Teething, Fluid-Filled

- Device class: 2; regulation: 21 CFR 872.5550; FDA's rule: 510(k) exempt
- FDA decisions: 27
- Recalls: 9 (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)
- 2000: 1
- 2002: 2
- 2003: 1
- 2005: 3
- 2006: 2
- 2007: 1
- 2009: 5
- 2010: 4
- 2011: 2
- 2013: 1

## Most-cited predicates
- K002066: Freezer Teether (2000), cited by 1
- K031094: Fluid Filled Teethers (2003), cited by 1
- K052105: Water Filled Teether (2005), cited by 1
- K092781: Mam Twister (2010), cited by 1

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