510(k) · Cleared
Recalled · Class II · 2016X-Force N30 Nephrostomy Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · LJE Catheter, Nephrostomy
Cleared on Jan 5, 2007 as substantially equivalent to K051316 (C.R. Bard, Inc., 2005) after a 30-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 5, 2007
- Review
- 30 days
- Class
- Class U
- Product code
- LJE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051316 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK051316 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2005
- This deviceK063632 X-Force N30 Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK080944 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK201165 In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051316 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2005 | — |
| 0 (this device) | K063632 | X-Force N30 Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2007 | — |
| +1 | K080944 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2008 | — |
| +2 | K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2020 | 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? (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 |
|---|---|---|---|
| * | K051316 | X-Force Nephrostomy Balloon Dilation CatheterSummary page 1…assified C. Predicate Device Name: Trade Name: X-Force TM N30 Nephrostomy Balloon Dilation Catheter # K051316 D. Device Description: The Bard X-ForceTM Nephrostomy catheter is composed of a dual lumen shaft with inflation and g… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080944 | X-Force Nephrostomy Balloon Dilation Catheter | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2016 | Class II | Z-0363-2017 | Unknown/Undetermined by firm | Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Bard X-ForceTM Nephrostomy Balloon Dilation Catheter is recommended for use in the
dilation of the nephrostomy tract and for placement of the working sheath.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063632: X-Force N30 Nephrostomy Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063632
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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