# K181713: Ultraxx Nephrostomy Balloon Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 17, 2018 after 50 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953522 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171601: Ultraxx Nephrostomy Balloon Catheter, Cook Incorporated (2018) Summary page 5.
- K032840: Atrion Medical QL Inflation Device, Atrion Medical Products, Inc. (2004) Summary page 5.

## Indications for use
The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract. The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

Source page: https://510kreport.com/device/K181713
Methodology: https://510kreport.com/methodology