# K042457: Uro Pro

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Oct 25, 2004 after 45 days
- Product code: LJH (System, Irrigation, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K936231 (1995). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K022449: Hystereoscopy Pump HM4, W.O.M. World of Medicine AG (2003) Summary page 1.
- K940983: The Karl Storz Uromat (TM), KARL STORZ Endoscopy-America, Inc. (1994) Summary page 1.
- K980808: Endo FMS Urology, Future Medical Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K180735: Endomat Select (2018), 2 descendants of its own
- K201355: Endomat Select, IBS Shaver Software, License (2020), 1 descendant of its own
- K261706: Endomat Select (UP220) (2026), 0 descendants of its own

## Recalls of this device
- Jun 20, 2014 · Class II · Z-2080-2014: Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.

## Indications for use
The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve the visibility of the surgical field during urologic procedures.

Source page: https://510kreport.com/device/K042457
Methodology: https://510kreport.com/methodology