# MNK: Endoscopic Bite Block

- Device class: 1; regulation: 21 CFR 876.1500; FDA's rule: 510(k) exempt
- FDA decisions: 6
- 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)
- 1990: 1
- 1992: 1
- 1993: 2
- 1994: 2

## Most-cited predicates
- K914978: Oxyguard (1992), cited by 2
- K896691: Bite Block (1990), cited by 1
- K931044: Oxy-Bloc (1993), cited by 1

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