# K022708: Klarity

- Pathway: 510(k) (Traditional)
- Applicant: Larson Products, Inc.
- Decided: Nov 12, 2002 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: 1 generation back to K935067 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K935067: Aquaplast, Wfr/Aquaplast Corp. (1994) Summary page 1.

## Most influential descendants
- K120335: Embrace Thermoplastic (2012), 2 descendants of its own
- K252174: AquaCast Mask (2025), 0 descendants of its own
- K192102: Thermoplastic Masks (2019), 0 descendants of its own

## Indications for use
Klarity Thermoplastic is to be used by, or under the supervision of licensed physicians for the stabilization of patients undergoing external beam Radiation Therapy.

Source page: https://510kreport.com/device/K022708
Methodology: https://510kreport.com/methodology