# K221469: PATI (Protector Against Tongue Injury)

- Pathway: 510(k) (Traditional)
- Applicant: Neurovice, LLC
- Decided: Feb 22, 2023 after 278 days
- Product code: JXL (Block, Bite)
- Device class: 2
- Regulation: 21 CFR 882.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992269 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172978: SurgeoBite, Surgovations, LLC (2017) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K221469
Methodology: https://510kreport.com/methodology