# K252884: Guided Aarhus Applicator Set

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems
- Decided: Nov 19, 2025 after 70 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: 6 generations back to K864210 (1986). 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)
- K222775: Aarhus Applicator Set, Varian Medical Systems, Inc. (2023) Summary page 5.

## Indications for use
The Guided Aarhus Applicator Set is indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus, and endometrium using HDR brachytherapy.

Source page: https://510kreport.com/device/K252884
Methodology: https://510kreport.com/methodology