# K992269: Ventil-a Oral Protector

- Pathway: 510(k) (Traditional)
- Applicant: Somatics, Inc.
- Decided: Oct 25, 1999 after 111 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172978: SurgeoBite (2017), 1 descendant of its own
- K050188: Epiguard (2005), 1 descendant of its own
- K221469: PATI (Protector Against Tongue Injury) (2023), 0 descendants of its own
- K201309: ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (2021), 0 descendants 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

## Indications for use
The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, and any circumstance requiring protection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).

Source page: https://510kreport.com/device/K992269
Methodology: https://510kreport.com/methodology