# K252717: MAASTRO Rectal Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: May 20, 2026 after 265 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K912555 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193240: Universal Cylinder Applicator Family, Varian Medical Systems, Inc. (2020) Summary page 5.

## Indications for use
The MAASTRO Rectal Applicator Set is intended for use for cancer treatment of the rectum using HDR brachytherapy.

Source page: https://510kreport.com/device/K252717
Methodology: https://510kreport.com/methodology