510(k) Report

510(k) · Cleared

Cleared

Somatics Mouth Guard (Bite Block)

K864181510(k) TraditionalCleared Nov 3, 19867-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

Somatics, Inc. · JXL Block, Bite

Cleared on Nov 3, 1986 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 3, 1986
Review
7 days
Class
Class II
Product code
JXL
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2015: 1 descendant cleared1990200020102020
  1. This deviceK864181 Somatics Mouth Guard (Bite Block)Somatics, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK050188 EpiguardEpisafe Medical Devices, Ltd. · 2005
  3. Descendant · 2 generations on · 0 of its ownK150518 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite…Dupaco, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K050188EpiguardEpisafe Medical Devices, Ltd. · 2005 · cites it directly1descendant
  • K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue…Dupaco, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864181Somatics Mouth Guard (Bite Block)Somatics, Inc.1986—
+1K050188EpiguardEpisafe Medical Devices, Ltd.2005—
+2K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and…Dupaco, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201510
FIG. 1 — Lineage of K864181, 1986–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K221469 PATI (Protector Against Tongue Injury)score 5.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K050188EpiguardEpisafe Medical Devices, Ltd.20051

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?

  • Of its descendants, K050188 (Episafe Medical Devices, Ltd., 2005) has gone furthest, with 1 descendant of its own.

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

2015: 12017: 12021: 12023: 1
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

2007: 12008: 122009: 32010: 142011: 52012: 42013: 32014: 32015: 52017: 12022: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—012
20090—03
20100—014
20110—05
20120—04
20130—03
20140—03
20151—05
20160—00
20171—01
20180—00
20190—00
20200—00
20211—00
20220—03
20231—00
20240—00
20250—00
20260—0—

More from Somatics, Inc.

7 FDA decisions under this applicant name. See the company

  • K992269Ventil-a Oral ProtectorSomatics, Inc. · 1999
  • K945120Thymatron 2000 Electroconvulsive SystemSomatics, Inc. · 1995
  • K890711Dual Graph (TM) Recorder-MonitorSomatics, Inc. · 1989
  • K890710Disposable Eeg/Ekg Electrode, Cat. #EedsSomatics, Inc. · 1989
  • K882809ThymapadSomatics, Inc. · 1988

Recent decisions in JXL

The JXL category page

  • K221469PATI (Protector Against Tongue Injury)Neurovice, LLC · 2023
  • K201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation · 2021
  • K172978SurgeoBiteSurgovations, LLC · 2017
  • K150518Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mmDupaco, Inc. · 2015
  • K050188EpiguardEpisafe Medical Devices, Ltd. · 2005

https://510kreport.com/device/K864181 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864181: Somatics Mouth Guard (Bite Block).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864181

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026