# K202747: Klarity Bolus

- Pathway: 510(k) (Traditional)
- Applicant: Klarity Medical & Equipment (GZ) Co., Ltd.
- Decided: May 14, 2021 after 235 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 K993742 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993742: Super Tissue, I.Z.I. Corp. (2000) Summary page 4.

## Indications for use
Klarity Bolus is indicated for radiation therapy clinical treatments as a tissue equivalent aid to correct for anatomical irregularities and deliver a prescribed dose to the skin and underlying tissue. Target population is Adult, Child and Infant, and Federal (USA) law restricts this device to sale by, or on the order of a physician. Klarity Bolus has been tested for tissue equivalency at 6 MV and 10 MV photon and at 6 MeV and 12 MeV electron energy levels. Further testing will be required to confirm performance with proton therapy systems.

Source page: https://510kreport.com/device/K202747
Methodology: https://510kreport.com/methodology