# K192102: Thermoplastic Masks

- Pathway: 510(k) (Traditional)
- Applicant: Aktina Medical Corporation
- Decided: Sep 25, 2019 after 51 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 6.

## Indications for use
Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for single patient use for the duration of the treatment.

Source page: https://510kreport.com/device/K192102
Methodology: https://510kreport.com/methodology