510(k) · Cleared
ClearedUltraxx Nephrostomy Balloon Catheter 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 Aug 17, 2018 as substantially equivalent to K171601 (Cook Incorporated, 2018) and 1 other predicate after a 50-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Aug 17, 2018
- Review
- 50 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953522 (1996). 9 ancestors in all, the oldest K952968 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 1 generation backK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- This deviceK181713 Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −3 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| 0 (this device) | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K171601 | Ultraxx Nephrostomy Balloon CatheterSummary page 5…Page 2 of 4 Predicate Devices: Ultraxx™ Nephrostomy Balloon Catheter (K171601) is the primary predicate device cleared for market by FDA on February 23, 2018. Cook Sphere Inflation Device (K032… | 2018 |
| * | K032840 | Atrion Medical QL Inflation DeviceSummary page 5…traxx™ Nephrostomy Balloon Catheter (K171601) is the primary predicate device cleared for market by FDA on February 23, 2018. Cook Sphere Inflation Device (K032840) is the secondary predicate device cleared for market by FDA on March 3, 2004. Device Description: The Ultraxx™ Nephros… | 2004 |
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 22 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 9 ancestors have 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. 2018, 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?
The Ultraxx™ Nephrostomy Balloon Catheter is used to dilate the musculofascial tract, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181713: Ultraxx Nephrostomy Balloon Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181713
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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