# K183374: GrayDuck Stent

- Pathway: 510(k) (Traditional)
- Applicant: Poll Medical, LLC
- Decided: Feb 26, 2019 after 82 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: 3 generations back to K934523 (1995). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153270: TruGuard Custom Tongue and Jaw Positioner, Bionix Development Corp. (2016) Summary page 5.

## Most influential descendants
- K232293: kallisio stentra™ oral stent (2023), 0 descendants of its own
- K231852: BinkieRT (2023), 0 descendants of its own

## Indications for use
The GrayDuck Stent™ custom tongue and jaw positioner from POLL Medical LLC is intended to be used for repeat positioning and immobilization of a patient’s tongue and jaw while undergoing or receiving a course of external beam radiation therapy for treatment of cancer and other diseases. The GrayDuck Stent is intended to be used by or under the direction of a licensed physician.

Source page: https://510kreport.com/device/K183374
Methodology: https://510kreport.com/methodology