510(k) · Cleared

Cleared

Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm

K150518510(k) TraditionalCleared Jun 29, 2015119-day reviewClass II21 CFR 882.5070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jun 29, 2015 as substantially equivalent to K050188 (Episafe Medical Devices, Ltd., 2005) and 1 other predicate after a 119-day review. Its family tree reaches back 2 generations to 1986.

Decided: Jun 29, 2015
Review: 119 days
Class: Class II
Product code: JXL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K864181 (1986). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK864181 Somatics Mouth Guard (Bite Block)Somatics, Inc. · 1986
1 generation backK050188 EpiguardEpisafe Medical Devices, Ltd. · 2005
This deviceK150518 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite…Dupaco, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K864181	Somatics Mouth Guard (Bite Block)	Somatics, Inc.	1986	—
−1	K050188	Epiguard	Episafe Medical Devices, Ltd.	2005	—
0 (this device)	K150518	Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and…	Dupaco, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K150518, 1986–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JXL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JXL device

#1 K221469 PATI (Protector Against Tongue Injury)score 5.2 · 2 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K050188	Epiguard Summary page 4 …n Name Bite Block Regulation 882.5070 Product Code JXL, CAE Predicates Epiguard (K050188) Veni-A-Oral Protector (K992269) Description The Airway with Bite Block and Tongue De…	Episafe Medical Devices, Ltd.	2005	—
*	K992269	Ventil-a Oral Protector Summary page 4 …882.5070 Product Code JXL, CAE Predicates Epiguard (K050188) Veni-A-Oral Protector (K992269) Description The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will al…	Somatics, Inc.	1999	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 18.5 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All JXL devices

JXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JXL

1in 2023

2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXL

Too few JXL 510(k)s in any year since 2007 to give a median.

Recalls per year · JXL

No recall names JXL since 2007.

Adverse event reports per year · JXL

3in 2022

2007high 14 (2010) · low 0 (2016)2025

MAUDE reports naming product code JXL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	1
2008	0	—	12
2009	0	—	3
2010	0	—	14
2011	0	—	5
2012	0	—	4
2013	0	—	3
2014	0	—	3
2015	1	—	5
2016	0	—	0
2017	1	—	1
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	3
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150518 · printed Nov 5, 2026

Cite this page

510(k) Report. “K150518: Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150518

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026