# K150518: Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm

- Pathway: 510(k) (Traditional)
- Applicant: Dupaco, Inc.
- Decided: Jun 29, 2015 after 119 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: 2 generations back to K864181 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050188: Epiguard, Episafe Medical Devices, Ltd. (2005) Summary page 4.
- K992269: Ventil-a Oral Protector, Somatics, Inc. (1999) Summary page 4.

## Indications for use
The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive Therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.

Source page: https://510kreport.com/device/K150518
Methodology: https://510kreport.com/methodology