510(k) · Cleared
ClearedKsea Uropump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · LJH System, Irrigation, Urological
Cleared on Jul 8, 1998 after a 63-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jul 8, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- LJH
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK981615 Ksea UropumpKARL STORZ Endoscopy-America, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK162992 Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981615 | Ksea Uropump | KARL STORZ Endoscopy-America, Inc. | 1998 | — |
| +1 | K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | 2017 | — |
| +2 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162992 | Karl Storz UROMAT E.A.S.I. | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K162992 (Karl Storz Endoscopy America, Inc., 2017) has gone furthest, with 1 descendant of its own.
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?
These instruments are intended for use by qualified surgeons and are used for the infusion of sterile irrigation solution into the ureter and upper urinary tract, or used as a suction pump in conjunction with the Calcuson Ultrasonic Lithotriptor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981615: Ksea Uropump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981615
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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