510(k) · Cleared
ClearedIntroducer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Youcare Technology Co.,Ltd. (Wuhan) · LJE Catheter, Nephrostomy
Cleared on May 22, 2023 as substantially equivalent to K183035 (Cook Incorporated, 2019) after a 257-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- May 22, 2023
- Review
- 257 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K844090 (1984). No later device cites it as a predicate yet.
- Root · 2 generations backK844090 Percutaneous Nephrostomy Trocar SysAmerican Edwards Laboratories · 1984
- 1 generation backK183035 Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable…Cook Incorporated · 2019
- This deviceK222705 Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844090 | Percutaneous Nephrostomy Trocar Sys | American Edwards Laboratories | 1984 | — |
| −1 | K183035 | Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part… | Cook Incorporated | 2019 | — |
| 0 (this device) | K222705 | Introducer Needle | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
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 |
|---|---|---|---|
| * | K183035 | Percutaneous Entry Set, Skinny Needle (R) with Chiba Tip, Disposable Two-part Trocar…Summary page 4…abbreviated as Model A, Model B, Model C) Classification Panel: Gastroenterology/Urology Product Code: LJE Device Classification: Unclassified 4. The Predicate Devices K183035 Percutaneous Entry Set This predicate has not been subject to a design-related recall. No reference devices were used in this su… | 2019 |
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 39 years and passes through 3 companies; a new generation was cleared every 34.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
It is used for percutaneous puncture to the renal pelvis, establishing a percutaneous approach and providing working access for endoscopes and surgical instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222705 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222705: Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222705
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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