# OBB: Kit, Conception-Assist, Home Use

- Device class: 2; regulation: 21 CFR 884.5250; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 0 (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)
- 2007: 1
- 2008: 1
- 2012: 1
- 2014: 1

## Most-cited predicates
- K063227: Conceivex Conception Kit (2007), cited by 2
- K112200: Focus Touch Conception System (2012), cited by 1

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