510(k) · Decided
Recalled · Class II · 2020Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LJE Catheter, Nephrostomy
Cleared on Mar 27, 2019 as substantially equivalent to K140085 (Cook Incorporated, 2014) and 1 other predicate after a 268-day review. Its family tree reaches back 2 generations to 1981. It has been recalled 2 times.
- Decided
- Mar 27, 2019
- Review
- 268 days
- Class
- Class U
- Product code
- LJE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K810368 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK810368 Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 1981 · Recalled
- 1 generation backK140085 Universa Percultaneous Drainage CatheterCook Incorporated · 2014
- This deviceK181735 Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy…Cook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810368 | Vance Percutaneous Malecot Nephrostomy | Vance Products, Inc. | 1981 | 3 |
| −1 | K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | 2014 | — |
| 0 (this device) | K181735 | Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 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? (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 |
|---|---|---|---|
| * | K140085 | Universa Percultaneous Drainage CatheterSummary page 5…ied, Gastroenterology/Urology Predicate Device: The predicate device is the Universa Percutaneous Drainage Catheter cleared under 510(k) Premarket Notification number K140085. The secondary predicate is Angiomed’s Pediatric Percutaneous Nephrostomy Set cleared under K854909. Device Description: The Pe… | 2014 |
| * | K854909 | Pediatric Percutaneous Nephrostomy SetsSummary page 5…Drainage Catheter cleared under 510(k) Premarket Notification number K140085. The secondary predicate is Angiomed’s Pediatric Percutaneous Nephrostomy Set cleared under K854909. Device Description: The Percutaneous Neonatal Pigtail Nephrostomy Set comprises a 6.0 French (Fr) pigtail drainage catheter, a… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2020 | Class II | Z-0105-2021 | No Marketing Application | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed… |
| Aug 31, 2020 | Class II | Z-0106-2021 | No Marketing Application | The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 2 companies; a new generation was cleared every 33.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 4 other devices also cite its predicate K140085.
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?
This device is intended for percutaneous placement of a pigtail catheter in the renal pelvis for nephrostomy drainage in neonatal patients.
This device is used as a nephrostomy drainage catheter and ureteral stent in pediatric patients 2 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181735: Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181735
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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