# K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 18, 2012 after 109 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952968 (1995). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952968: Dilatation Catheter, Balloon, Boston Scientific Corp (1995) Summary page 1.

## Most influential descendants
- K130804: Uromax Ultra Balloon Dilatation Catheter (2013), 4 descendants of its own
- K171601: Ultraxx Nephrostomy Balloon Catheter (2018), 1 descendant of its own
- 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

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2535-2025: 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
- May 28, 2013 · Class II · Z-1673-2013: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
- May 28, 2013 · Class II · Z-1672-2013: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

## Indications for use
The NephromaxTM High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy tract.

Source page: https://510kreport.com/device/K121614
Methodology: https://510kreport.com/methodology