510(k) · Cleared
ClearedVentil-a Oral Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somatics, Inc. · JXL Block, Bite
Cleared on Oct 25, 1999 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 25, 1999
- Review
- 111 days
- Class
- Class II
- Product code
- JXL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK992269 Ventil-a Oral ProtectorSomatics, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK172978 SurgeoBiteSurgovations, LLC · 2017
- Descendant · cites it directly · 1 of its ownK050188 EpiguardEpisafe Medical Devices, Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK221469 PATI (Protector Against Tongue Injury)Neurovice, LLC · 2023
- Descendant · cites it directly · 0 of its ownK201309 ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation · 2021
- 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 5 of 5 · See all- K172978SurgeoBiteSurgovations, LLC · 2017 · cites it directly1descendant
- K050188EpiguardEpisafe Medical Devices, Ltd. · 2005 · cites it directly1descendant
- K221469PATI (Protector Against Tongue Injury)Neurovice, LLC · 2023 · 2 generations on0descendants
- K201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta Corporation · 2021 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K992269 | Ventil-a Oral Protector | Somatics, Inc. | 1999 | — |
| +1 | K172978 | SurgeoBite | Surgovations, LLC | 2017 | — |
| +1 | K050188 | Epiguard | Episafe Medical Devices, Ltd. | 2005 | — |
| +2 | K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023 | — |
| +1 | K201309 | ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium | Mecta Corporation | 2021 | — |
| +1 | K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and… | Dupaco, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K172978 (Surgovations, LLC, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JXL devicesJXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXL
1in 2023
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, and any circumstance requiring protection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992269: Ventil-a Oral Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992269
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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