# K190255: Sensus Healthcare TVM Balloon Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare, Inc.
- Decided: Feb 21, 2019 after 14 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: 8 generations back to K864210 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090914: Axxent Balloon Applicator, Model AB2034, AB2045, AB2056, AB2057E, AB2067E, Xoft, Inc. (2009) Summary page 4.

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

Source page: https://510kreport.com/device/K190255
Methodology: https://510kreport.com/methodology