# K130804: Uromax Ultra Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: May 22, 2013 after 58 days
- Product code: EZN (Dilator, Catheter, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K952968 (1995). 3 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980795: Urological Balloon Dilatation Catheter, Boston Scientific Corp (1998) Summary page 1.
- K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter, Boston Scientific Corp (2012) Summary page 1.

## Most influential descendants
- K250910: Optilume® High Pressure Urological Balloon Dilation Catheter (2025), 0 descendants of its own
- K191061: Optilume Basic Urological Balloon Dilation Catheter (2020), 0 descendants of its own
- K190612: EQUINOX Balloon Dilatation Catheter (2019), 0 descendants of its own
- K132181: Gyrus Acmi Uro-Ezdilate Ureteral Balloon Dilation Catheter (2013), 0 descendants of its own

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2536-2025: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, f

## Indications for use
Uromax Ultra TM Balloon Dilatation Catheters are recommended for dilatation of the urinary tract.

Source page: https://510kreport.com/device/K130804
Methodology: https://510kreport.com/methodology