510(k) · Cleared

Cleared

Epiguard

K050188510(k) TraditionalCleared Apr 27, 200590-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

Episafe Medical Devices, Ltd. · JXL Block, Bite

Cleared on Apr 27, 2005 as substantially equivalent to K992269 (Somatics, Inc., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: Apr 27, 2005
Review: 90 days
Class: Class II
Product code: JXL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K864181 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK864181 Somatics Mouth Guard (Bite Block)Somatics, Inc. · 1986
This deviceK050188 EpiguardEpisafe Medical Devices, Ltd. · 2005
Descendant · cites it directly · 0 of its ownK150518 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite…Dupaco, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…Dupaco, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864181	Somatics Mouth Guard (Bite Block)	Somatics, Inc.	1986	—
0 (this device)	K050188	Epiguard	Episafe Medical Devices, Ltd.	2005	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K050188, 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K992269	Ventil-a Oral Protector Summary page 1 …lassification Bite Block, Class 2, Product Code 84JXL, 21 CFR 882.5070 Name: EpiGuard 3. Predicate Devices: Ventil-A Bite Block K992269 MouthGuard Bite Block K864181 Sage Bite Block Pre-Amendment 4.…	Somatics, Inc.	1999	—
*	K864181	Somatics Mouth Guard (Bite Block) Summary page 1 …, 21 CFR 882.5070 Name: EpiGuard 3. Predicate Devices: Ventil-A Bite Block K992269 MouthGuard Bite Block K864181 Sage Bite Block Pre-Amendment 4. Description: The EpiGuard is a single use oral pro…	Somatics, Inc.	1986	—
*	—	Sage Bite Block Pre-Amendment Named without a submission number			—

Also cleared against K992269: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150518	Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…	Dupaco, Inc.	2015	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K150518 (Dupaco, Inc., 2015) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K992269.

How does its category compare?

All JXL devices

JXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050188: Epiguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050188

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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