# K132383: Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Feb 4, 2014 after 188 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: 2 generations back to K952968 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Oct 17, 2025 · Class II · Z-0572-2026: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in 

## Indications for use
The Gyrus ACMI Nepbro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.

Source page: https://510kreport.com/device/K132383
Methodology: https://510kreport.com/methodology