510(k) · Cleared
ClearedKarl Storz UROMAT E.A.S.I.
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 7, 2017 as substantially equivalent to K981615 (KARL STORZ Endoscopy-America, Inc., 1998) and 1 other predicate after a 253-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jul 7, 2017
- Review
- 253 days
- Class
- Class II
- Product code
- LJH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981615 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K213334Monarch Platform, UrologyAuris Health, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981615 | Ksea Uropump | KARL STORZ Endoscopy-America, Inc. | 1998 | — |
| 0 (this device) | K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | 2017 | — |
| +1 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K981615 | Ksea UropumpSummary page 4…Urological catheter and accessories Panel: Gastroenterology/Urology Product Code(s): LJH 3. Predicate Devices 510(k) number: K981615 K010569 Device Trade Name: Karl Storz Uropump Karl Storz Universal Lapa… | 1998 |
| * | K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpSummary page 4…sories Panel: Gastroenterology/Urology Product Code(s): LJH 3. Predicate Devices 510(k) number: K981615 K010569 Device Trade Name: Karl Storz Uropump Karl Storz Universal Laparomat Common Name: System, I… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213334 | Monarch Platform, Urology | 2022 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K213334 (Auris Health, Inc., 2022) has gone furthest, with 0 descendants 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. 2017, this device’s year, is highlighted.
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 UROMAT E.A.S.I. is used for the introduction of irrigation fluids into organs and operating fields as well as the suctioning off of irrigation and bodily fluids, secretions and tissue during endoscopic interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162992 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162992: Karl Storz UROMAT E.A.S.I..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162992
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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