# K050188: Epiguard

- Pathway: 510(k) (Traditional)
- Applicant: Episafe Medical Devices, Ltd.
- Decided: Apr 27, 2005 after 90 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
Longest line of descent: 1 generation back to K864181 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992269: Ventil-a Oral Protector, Somatics, Inc. (1999) Summary page 1.
- K864181: Somatics Mouth Guard (Bite Block), Somatics, Inc. (1986) Summary page 1.
- (no number) Sage Bite Block Pre-Amendment: named in the summary without a submission number

## Most influential descendants
- 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

## Indications for use
The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.

Source page: https://510kreport.com/device/K050188
Methodology: https://510kreport.com/methodology