# K103215: Cianna S1, Single Lumen Balloon Applicator Kit

- Pathway: 510(k) (Traditional)
- Applicant: Cianna Medical
- Decided: Nov 15, 2010 after 14 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041929: Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray, Proxima Therapeutics, Inc. (2004) Summary page 1.

## Indications for use
The Cianna SI, Single Lumen Balloon Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Source page: https://510kreport.com/device/K103215
Methodology: https://510kreport.com/methodology