510(k) · Cleared
Recalled · Class II · 2014Uro Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine AG · LJH System, Irrigation, Urological
Cleared on Oct 25, 2004 as substantially equivalent to K022449 (W.O.M. World of Medicine AG, 2003) and 2 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 25, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- LJH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K936231 (1995). 6 ancestors in all, the oldest K940983 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK936231 The Karl Storz Hamou EndomatKarl Storz Endoscopy · 1995
- 1 generation backK022449 Hystereoscopy Pump HM4W.O.M. World of Medicine AG · 2003
- This deviceK042457 Uro ProW.O.M. World of Medicine AG · 2004
- Descendant · cites it directly · 2 of its ownK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · 2 generations on · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 3 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936231 | The Karl Storz Hamou Endomat | Karl Storz Endoscopy | 1995 | — |
| −1 | K022449 | Hystereoscopy Pump HM4 | W.O.M. World of Medicine AG | 2003 | — |
| 0 (this device) | K042457 | Uro Pro | W.O.M. World of Medicine AG | 2004 | — |
| +1 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +2 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +3 | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LJH device
- #1 K254111 Irrigation/Urology Setsscore 12.0 · 1 generation · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022449 | Hystereoscopy Pump HM4Summary page 1…Product Classification: Product Code: LHJ Device Class: II IV. Predicate Devices: * Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD OF MEDICINE AG * Karl Storz Uromat (K940983) manufactured by Karl Storz… | 2003 |
| * | K940983 | The Karl Storz Uromat (TM)Summary page 1…IV. Predicate Devices: * Hysteroscopy Pump HM4 (K022449) manufactured by W.O.M. WORLD OF MEDICINE AG * Karl Storz Uromat (K940983) manufactured by Karl Storz Endoscopy- America, Inc. * ENDO FMS Urology (K980808) manufactured by Fut… | 1994 |
| * | K980808 | Endo FMS UrologySummary page 1…OF MEDICINE AG * Karl Storz Uromat (K940983) manufactured by Karl Storz Endoscopy- America, Inc. * ENDO FMS Urology (K980808) manufactured by Future Medical Systems, Inc. V. Intended Use. The URO Pro is an irrig… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180735 | Endomat Select | 2018 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2014 | Class II | Z-2080-2014 | Other | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K180735 (Karl Storz SE & CO. KG, 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K022449.
How does its category compare?
All LJH devicesLJH System, Irrigation, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJH
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · LJH
77in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJH
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJH
25in 2025
MAUDE reports naming product code LJH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 77 | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 27 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 97 |
| 2015 | 0 | — | 0 | 642 |
| 2016 | 0 | — | 0 | 32 |
| 2017 | 1 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042457: Uro Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042457
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026