510(k) · Cleared
Recalled · Class II · 2016Cook Nephrostomy Dilation Balloon Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · LJE Catheter, Nephrostomy
Cleared on Feb 27, 2003 after an 80-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 27, 2003
- Review
- 80 days
- Class
- Class U
- Product code
- LJE
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK024050 Cook Nephrostomy Dilation Balloon Catheter SetCook Urological, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK171601 Ultraxx Nephrostomy Balloon CatheterCook Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK172929 Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear…Boston Scientific Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK213334 Monarch Platform, UrologyAuris Health, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK181713 Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018
Most influential descendants
Showing 4 of 4 · See all- K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated · 2018 · cites it directly1descendant
- K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation · 2018 · cites it directly1descendant
- K213334Monarch Platform, UrologyAuris Health, Inc. · 2022 · 2 generations on0descendants
- K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024050 | Cook Nephrostomy Dilation Balloon Catheter Set | Cook Urological, Inc. | 2003 | — |
| +1 | K171601 | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | 2018 | — |
| +1 | K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal… | Boston Scientific Corporation | 2018 | — |
| +2 | K213334 | Monarch Platform, Urology | Auris Health, Inc. | 2022 | 1 |
| +2 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | other Nephrostomy Dilation Balloons manufactured and marketed by Cook Urological Named without a submission number | |
| * | — | NephroMax Balloon Dilatation Catheter Sets marketed by Boston Scientific/Microvasive Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2016 | Class II | Z-1238-2016 | Labeling mix-ups | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as… |
| Jan 27, 2016 | Class II | Z-1237-2016 | Labeling mix-ups | Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171601 (Cook Incorporated, 2018) has gone furthest, with 1 descendant 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?
The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used
for one step, dilation of the musculofascial nephrostomy tract and
placement of the working sheath.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024050: Cook Nephrostomy Dilation Balloon Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024050
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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