# K260308: TrueFit Bolus

- Pathway: 510(k) (Special)
- Applicant: Adaptiiv Medical Technologies, Inc.
- Decided: Feb 19, 2026 after 20 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: 8 generations back to K971367 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243057: TrueFit Bolus; TrueFlex Bolus, Adaptiiv Medical Technologies, Inc. (2024) Summary page 5.

## Indications for use
TrueFit Bolus is indicated for and intended to be placed on the patient's skin as an accessory to attenuate and/or compensate external beam (photon or electron) radiation during prescribed radiation therapy for the treatment of cancer or other non-malignant tissue conditions for which radiation therapy is indicated. The device is for a single patient's use only and can be reused throughout the entirety of the treatment course. The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use. The device is restricted to sale by or on the order of a physician and is by prescription only.

Source page: https://510kreport.com/device/K260308
Methodology: https://510kreport.com/methodology