# K051593: Uropass Ureteral Access Sheath, Model 61224

- Pathway: 510(k) (Traditional)
- Applicant: Acmi Corporation
- Decided: Sep 2, 2005 after 78 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961904 (1996). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981611: Snap-N-Peel Introducers, Circon Corp. (1998) Summary page 1.
- K993650: Ureteral Access Sheath Set - New Models, Applied Medical Resources (1999) Summary page 1.

## Most influential descendants
- K120160: Rocamed Rocaus Platinum (2012), 2 descendants of its own
- K140441: BI-Flex Ureteral Access Sheath (2014), 1 descendant of its own
- K123170: Vari-Pass Variable Length Access Sheath (2013), 1 descendant of its own
- K182403: Peel-Away Introducer (2019), 0 descendants of its own
- K182144: Bi-Flex Evo (2018), 0 descendants of its own

## Recalls of this device
- Sep 11, 2024 · Class II · Z-0364-2025: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical pro
- May 19, 2023 · Class II · Z-2401-2023: Dilator tips may break in the package and in patients during surgical procedures.

## Indications for use
Intended to be a conduit for the passage of endoscopes and other urological devices for the purpose of performing diagnostic and surgical procedures, such as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.

Source page: https://510kreport.com/device/K051593
Methodology: https://510kreport.com/methodology