510(k) · Cleared
ClearedDisposable Percutaneous Nephrostomy Dilatation Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Trious Medical Technology Co., Ltd. · LJE Catheter, Nephrostomy
Cleared on Jul 3, 2025 as substantially equivalent to K170531 (Coloplast Corp., 2017) after a 135-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Jul 3, 2025
- Review
- 135 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961904 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 1 generation backK170531 Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. · 2017 · Recalled
- This deviceK250448 Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −1 | K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | 2017 | 1 |
| 0 (this device) | K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. | 2025 | — |
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 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 K222705 Introducer Needlescore 5.7 · 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? (1)
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 |
|---|---|---|---|
| * | K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsSummary page 5…Class: Class II Product code: EZN Review Panel: Gastroenterology/Urology III. Predicate Devices 510(k) Number: K170531 Trade name: Ureteral Dilators and Percutaneous Nephrostomy Dilators Common name: Ureteral Dilato… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 20.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
Disposable Percutaneous Nephrostomy Dilators:
Dilator for tract preparation and splittable working sheath to protect the parenchyma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250448: Disposable Percutaneous Nephrostomy Dilatation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250448
Report an extraction error
Are you the manufacturer?
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