# K200652: Lollipop BiteBlock

- Pathway: 510(k) (Traditional)
- Applicant: Radtec Medical Devices, Inc.
- Decided: Jul 6, 2020 after 116 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.
No later device cites it as a predicate yet.
0 of 4 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 4.

## Indications for use
The Lollipop BiteBlock from RadTec Medical Devices, Inc. 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/K200652
Methodology: https://510kreport.com/methodology