# K160021: Varian Sterilization Boxes

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 13, 2016 after 99 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: 2 generations back to K871216 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980576: Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader, Varian Medical Systems, Inc. (1998) Summary page 4.

## Indications for use
The Varian Sterilization boxes are intended to securely store the applicator parts during steam sterilization process and subsequent storage.

Source page: https://510kreport.com/device/K160021
Methodology: https://510kreport.com/methodology