# K072749: Sialo Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Sialo Technology, Ltd.
- Decided: May 14, 2008 after 230 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970041 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012527: Ksea Sialoendoscopes and Accessories, KARL STORZ Endoscopy-America, Inc. (2001) Summary page 1.
- K970041: Ascend Balloon Dailation Catheter, Cook Urological, Inc. (1997) Summary page 2.
- (no number) Salivary Duct Dilator: named in the summary without a submission number

## Most influential descendants
- K140593: Advance Salivary Balloon Catheter with Wire Guide (2014), 0 descendants of its own

## Indications for use
The Sialo Balloon dilatation catheter is a medical device for use by qualified surgeons in the treatment of salivary gland diseases.

Source page: https://510kreport.com/device/K072749
Methodology: https://510kreport.com/methodology