# K063632: X-Force N30 Nephrostomy Balloon Dilation Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 5, 2007 after 30 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- 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: 1 generation back to K051316 (2005). 1 ancestor in all.
2 later devices descend 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)
- K051316: X-Force Nephrostomy Balloon Dilation Catheter, C.R. Bard, Inc. (2005) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Oct 12, 2016 · Class II · Z-0363-2017: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

## Indications for use
The Bard X-ForceTM 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/K063632
Methodology: https://510kreport.com/methodology