# K131150: Cura Compensator

- Pathway: 510(k) (Traditional)
- Applicant: Cura Medical Technologies, LLC
- Decided: Jul 30, 2013 after 98 days
- Product code: IXI (Block, Beam-Shaping, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000137 (2000). 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)
- K071078: .Decimal Range Compensator, .Decimal, Inc. (2007) Summary page 2.
- K121657: Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range Compensator, Proton Systems (2012) Summary page 2.

## Indications for use
The Cura Compensator is a solid, machine-shaped acrylic block intended to attenuate external radiation beam and block radiation from hitting critical structures and healthy tissue while allowing the radiation dose to the targeted area. The Cura Compensator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

Source page: https://510kreport.com/device/K131150
Methodology: https://510kreport.com/methodology