510(k) · Decided
DecidedIn-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · LJE Catheter, Nephrostomy
Cleared on Dec 17, 2020 as substantially equivalent to K080944 (C.R. Bard, Inc., 2008) after a 230-day review. Its family tree reaches back 3 generations to 2005.
- Decided
- Dec 17, 2020
- Review
- 230 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K051316 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backK051316 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2005
- 2 generations backK063632 X-Force N30 Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK080944 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2008
- This deviceK201165 In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K051316 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2005 | — |
| −2 | K063632 | X-Force N30 Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2007 | 1 |
| −1 | K080944 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | 2020 | — |
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 |
|---|---|---|---|
| * | K080944 | X-Force Nephrostomy Balloon Dilation CatheterSummary page 4…Device Class: Unclassified III. PREDICATE DEVICE Bard X-ForceTM N30 Nephrostomy Balloon Dilation Catheters, cleared under premarket notification number K080944 The predicate device has the following indication for use: • Dilation of the nephrostomy tract and placement of the working s… | 2008 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has 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. 2020, 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 In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the duration of the percutaneous tract dilation).
The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201165: In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201165
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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