510(k) · Decided
DecidedPercutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LJE Catheter, Nephrostomy
Cleared on May 17, 2019 as substantially equivalent to K844090 (American Edwards Laboratories, 1984) after a 197-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.
- Decided
- May 17, 2019
- Review
- 197 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844090 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK844090 Percutaneous Nephrostomy Trocar SysAmerican Edwards Laboratories · 1984
- This deviceK183035 Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable…Cook Incorporated · 2019
- Descendant · cites it directly · 0 of its ownK222705 Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023
Most influential descendants
Showing 1 of 1 · See all- K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844090 | Percutaneous Nephrostomy Trocar Sys | American Edwards Laboratories | 1984 | — |
| 0 (this device) | K183035 | Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part… | Cook Incorporated | 2019 | — |
| +1 | K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K844090 | Percutaneous Nephrostomy Trocar SysSummary page 6…ified Classification Panel: Gastroenterology/Urology Predicate Device: - Percutaneous Nephrostomy Trocar System, American Edward Laboratories, K844090 Device Description: - Percutaneous Entry Set The Percutaneous Entry Set is comprised of a Skinny Needle® with Chiba Tip, a… | 1984 |
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 |
|---|---|---|---|
| K222705 | Introducer Needle | 2023 | 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?
- Its one ancestor has no recall.
- Of its descendants, K222705 (Youcare Technology Co.,Ltd. (Wuhan), 2023) has gone furthest, with 0 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. 2019, 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?
Used to establish a percutaneous tract into the renal pelvis for catheter placement or stone manipulation.
Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.
Used under fluoroscopy or ultrasound for initial location and positioning within the renal collecting system during a percutaneous nephrostomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183035: Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183035
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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