510(k) · Cleared
ClearedUresil Percutaneous Drainage Catheters with Hydrophilic Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uresil Corp. · LJE Catheter, Nephrostomy
Cleared on Sep 10, 1998 after a 154-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 10, 1998
- Review
- 154 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK981344 Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
- Descendant · cites it directly · 2 of its ownK063733 Resolve Biliary Drainage CatheterMerit Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK121832 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK141408 Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K063733Resolve Biliary Drainage CatheterMerit Medical Systems, Inc. · 2007 · cites it directly2descendants
- K121832Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2012 · 2 generations on1descendant
- K141408Resolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic Coating | Uresil Corp. | 1998 | — |
| +1 | K063733 | Resolve Biliary Drainage Catheter | Merit Medical Systems, Inc. | 2007 | 4 |
| +2 | K121832 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2012 | 1 |
| +3 | K141408 | Resolve Biliary Locking Drainage Catheter | Merit Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LJE? 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 LJE device
- #1 K250448 Disposable Percutaneous Nephrostomy Dilatation…score 9.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K063733 | Resolve Biliary Drainage Catheter | 2007 | 2 |
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, K063733 (Merit Medical Systems, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJE
254in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJE
59in 2025
MAUDE reports naming product code LJE, 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 | 1 | — | 1 | 5 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 26 |
| 2017 | 1 | — | 0 | 60 |
| 2018 | 3 | 107 | 0 | 69 |
| 2019 | 4 | 254 | 1 | 78 |
| 2020 | 2 | — | 2 | 50 |
| 2021 | 0 | — | 1 | 38 |
| 2022 | 1 | — | 0 | 42 |
| 2023 | 1 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 47 |
| 2025 | 1 | — | 1 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For percutaneous drainage of abscess, nephrostomy and other fluids.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981344: Uresil Percutaneous Drainage Catheters with Hydrophilic Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981344
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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