# K232293: kallisio stentra™ oral stent

- Pathway: 510(k) (Traditional)
- Applicant: Kallisio, Inc.
- Decided: Dec 22, 2023 after 143 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934523 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183374: GrayDuck Stent, Poll Medical, LLC (2019) Summary page 4.

## Indications for use
The kallisio Stentra™ oral stent is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing a course of external beam radiation therapy for treatment of cancer and other diseases. The kallisio Stentra oral stent is intended to be used by or under the direction of a I icensed physician.

Source page: https://510kreport.com/device/K232293
Methodology: https://510kreport.com/methodology