# K252174: AquaCast Mask

- Pathway: 510(k) (Traditional)
- Applicant: Blessing Cathay Corporation
- Decided: Sep 3, 2025 after 54 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 K935067 (1994). 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)
- K120335: Embrace Thermoplastic, Bionix Development Corp. (2012) Summary page 5.

## Indications for use
AquaCast Mask is a device used for the positioning and immobilization of patient's head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Thermoplastic Mask is intended as a single-patient reusable device only and are not sterile.

Source page: https://510kreport.com/device/K252174
Methodology: https://510kreport.com/methodology