# K201309: ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium

- Pathway: 510(k) (Traditional)
- Applicant: Mecta Corporation
- Decided: Jun 4, 2021 after 385 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 K992269 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
The ECT Cotton Bite Block is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy (ECT), to protect the patient’s lips, teeth and tongue. It is placed between the back molars, with the tongue medial, and one side of the bite block sticking out of the patient's mouth to keep the mouth open.

Source page: https://510kreport.com/device/K201309
Methodology: https://510kreport.com/methodology