# K864181: Somatics Mouth Guard (Bite Block)

- Pathway: 510(k) (Traditional)
- Applicant: Somatics, Inc.
- Decided: Nov 3, 1986 after 7 days
- Product code: JXL (Block, Bite)
- Device class: 2
- Regulation: 21 CFR 882.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050188: Epiguard (2005), 1 descendant of its own
- K150518: Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K864181
Methodology: https://510kreport.com/methodology