510(k) · Decided
DecidedKaye Nephrostomy Tamponade Balloon Catheter and 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 Jul 16, 2019 as substantially equivalent to K915209 (Cook Urological, Inc., 1992) and 1 other predicate after a 256-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jul 16, 2019
- Review
- 256 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924608 (1994). 3 ancestors in all, the oldest K915209 (1992). No later device cites it as a predicate yet.
- Root · 2 generations backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- 1 generation backK141344 Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel…Boston Scientific Corp · 2014
- This deviceK183051 Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| −1 | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral… | Boston Scientific Corp | 2014 | — |
| 0 (this device) | K183051 | Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set | Cook Incorporated | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 |
|---|---|---|---|
| * | K915209 | Malecot-Nephrostomy Tamponade CatheterSummary page 4…Unclassified Review Panel: Gastroenterology/Urology Predicate Devices: • Malecot-Nephrostomy Tamponade Catheter, Cook Incorporated, K915209 • Expel™ Nephroureteral Stent System with Twist-Loc Hub, Boston Scientific, K141344 Device Description: The Kaye Nephrostomy… | 1992 |
| * | K141344 | Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage…Summary page 4…cate Devices: • Malecot-Nephrostomy Tamponade Catheter, Cook Incorporated, K915209 • Expel™ Nephroureteral Stent System with Twist-Loc Hub, Boston Scientific, K141344 Device Description: The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is comprised of a balloon catheter, ureteral st… | 2014 |
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 25 years and passes through 2 companies; a new generation was cleared every 20.7 years on median.
- None of the 3 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. 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?
The Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is used for nephrostomy drainage, ureteral drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
The Kaye Nephrostomy Tamponade Balloon Catheter Set is used for nephrostomy drainage, and dynamic tamponade to prevent hemorrhage in nephrolithotomy and percutaneous stone removal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183051: Kaye Nephrostomy Tamponade Balloon Catheter and 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/K183051
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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