# K092822: Capri Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Vivaray, Inc.
- Decided: Nov 3, 2009 after 50 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: 5 generations back to K864210 (1986). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061241: Biolucent Applicator, Model Rta-XX, Biolucent, Inc. (2006) Summary page 1.
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 1.

## Most influential descendants
- K133922: Gentlecare AR Applicator (2014), 0 descendants of its own
- K120344: Radiapak Brachytherapy Applicator Balloon Device (2012), 0 descendants of its own

## Indications for use
The CAPRITM Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Source page: https://510kreport.com/device/K092822
Methodology: https://510kreport.com/methodology