# K051316: X-Force Nephrostomy Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 18, 2005 after 59 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Cook® Ultraxx™ Nephrostomy Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K063632: X-Force N30 Nephrostomy Balloon Dilation Catheter (2007), 2 descendants of its own
- K080944: X-Force Nephrostomy Balloon Dilation Catheter (2008), 1 descendant of its own
- K201165: In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath (2020), 0 descendants of its own

## Indications for use
The Bard® X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.

Source page: https://510kreport.com/device/K051316
Methodology: https://510kreport.com/methodology