# K211511: decimal Bolus

- Pathway: 510(k) (Traditional)
- Applicant: .Decimal, LLC
- Decided: Jul 1, 2021 after 48 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 5 generations back to K000137 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091911: Bolus Compensator, .Decimal, Inc. (2009) Summary page 5.

## Most influential descendants
- K252784: eXaSkin Plus (2026), 0 descendants of its own

## Indications for use
The decimal Bolus product is a solid piece of material (rigid or rubber-like) that will be placed on the skin of a patient with the intended use and primary purpose of helping control the dose received by that patient when undergoing radiation therapy treatment. decimal Bolus devices are designed by radiation therapy professionals to a unique shape that is specific to each patient being treated. The device is intended to modify the dose delivered during a radiation therapy treatment. As this product is a simple general purpose bolus device, the intended patient population and indications for use are quite broad. The most common indications for use are for the treatment of patients receiving radiation therapy, which encompasses a wide range of potential disease types and locations. As such, these devices will be required to have a wide range of potential shapes, sizes, and material properties and each device must be tested and approved by the radiation therapy professional prior to use on a patient.

Source page: https://510kreport.com/device/K211511
Methodology: https://510kreport.com/methodology