# K090914: Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E

- Pathway: 510(k) (Traditional)
- Applicant: Xoft, Inc.
- Decided: Jul 16, 2009 after 106 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- 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 K864210 (1986). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050843: Axxent Electronic Brachytherapy System, Xoft, Inc. (2005) Summary page 1.

## Most influential descendants
- K190255: Sensus Healthcare TVM Balloon Applicator (2019), 0 descendants of its own

## Indications for use
The Axxent Balloon Applicator is indicated for use with the Axxent Electronic Brachytherapy System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

Source page: https://510kreport.com/device/K090914
Methodology: https://510kreport.com/methodology