# K120335: Embrace Thermoplastic

- Pathway: 510(k) (Traditional)
- Applicant: Bionix Development Corp.
- Decided: May 3, 2012 after 90 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 K935067 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022708: Klarity, Larson Products, Inc. (2002) Summary page 2.
- K935067: Aquaplast, Wfr/Aquaplast Corp. (1994) Summary page 2.

## Most influential descendants
- K252174: AquaCast Mask (2025), 0 descendants of its own
- K192102: Thermoplastic Masks (2019), 0 descendants of its own

## Indications for use
Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support 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/K120335
Methodology: https://510kreport.com/methodology