510(k) · Cleared
ClearedPATI (Protector Against Tongue Injury)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurovice, LLC · JXL Block, Bite
Cleared on Feb 22, 2023 as substantially equivalent to K172978 (Surgovations, LLC, 2017) after a 278-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Feb 22, 2023
- Review
- 278 days
- Class
- Class II
- Product code
- JXL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992269 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K201309 ECT Cotton Bite Block- size Large, ECT Cotton…score 1.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K172978 | SurgeoBiteSummary page 4…Neurology Predicate Device: Manufacturer: Surgovations, LLC Trade Name: SurgeoBite 510(k): K172978 Device Description: The Protector Against Tongue Injury (PATI) device is a symptom-management, oral device technolog… | 2017 |
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 24 years and passes through 3 companies; a new generation was cleared every 18.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JXL devicesJXL Block, Bite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221469: PATI (Protector Against Tongue Injury).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221469
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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