510(k) · Cleared
ClearedSurgeoBite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgovations, LLC · JXL Block, Bite
Cleared on Dec 22, 2017 as substantially equivalent to K992269 (Somatics, Inc., 1999) after an 86-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Dec 22, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- JXL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992269 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K221469PATI (Protector Against Tongue Injury)Neurovice, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992269 | Ventil-a Oral Protector | Somatics, Inc. | 1999 | — |
| 0 (this device) | K172978 | SurgeoBite | Surgovations, LLC | 2017 | — |
| +1 | K221469 | PATI (Protector Against Tongue Injury) | Neurovice, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K992269 | Ventil-a Oral ProtectorSummary page 4…21 CFR 882.5070 Class: II Product Code: JXL Legally Marketed Predicate Device: Ventil-A - Somatics, LLC - 510(k) # K992269 Device Description: The SurgeoBite is designed to be an easy to use and safe device for use in the patient’s mouth.… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221469 | PATI (Protector Against Tongue Injury) | 2023 | 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?
How does its category compare?
All JXL devicesJXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172978: SurgeoBite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172978
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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