# K162265: CushionCast Moldable Cushions

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical Products, LLC
- Decided: Nov 15, 2016 after 96 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 K895697 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132124: Klarity Vacuum Bag, Klarity Mold Cushion, Klarity Medical Products, LLC (2013) Summary page 5.

## Indications for use
The CushionCast Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.

Source page: https://510kreport.com/device/K162265
Methodology: https://510kreport.com/methodology