# K153270: TruGuard Custom Tongue and Jaw Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: Mar 8, 2016 after 117 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: 2 generations back to K934523 (1995). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962155: Gill-Thomas-Cosman (GTC) Dental Tray, Radionics Software Applications, Inc. (1996) Summary page 5.

## Most influential descendants
- K183374: GrayDuck Stent (2019), 2 descendants of its own
- K232293: kallisio stentra™ oral stent (2023), 0 descendants of its own
- K231852: BinkieRT (2023), 0 descendants of its own
- K200652: Lollipop BiteBlock (2020), 0 descendants of its own

## Indications for use
The TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K153270
Methodology: https://510kreport.com/methodology