510(k) · Cleared
ClearedX-Force 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 Oct 23, 2008 as substantially equivalent to K051316 (C.R. Bard, Inc., 2005) and 1 other predicate after a 203-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Oct 23, 2008
- Review
- 203 days
- Class
- Class U
- Product code
- LJE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K051316 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051316 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2005
- 1 generation backK063632 X-Force N30 Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2007 · Recalled
- This deviceK080944 X-Force Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK201165 In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051316 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2005 | — |
| −1 | K063632 | X-Force N30 Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2007 | 1 |
| 0 (this device) | K080944 | X-Force Nephrostomy Balloon Dilation Catheter | C.R. Bard, Inc. | 2008 | — |
| +1 | K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | Coloplast Corp. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051316 | X-Force Nephrostomy Balloon Dilation CatheterSummary page 1…- Unclassified C. Predicate Device Name: Trade Name: X-ForceTm N30 Nephrostomy Balloon Dilation Catheter # K051316 and K063632 D. Device Description: The Bard X-ForceTm Nephrostomy catheter is composed of a dual lumen shaft with inflation… | 2005 |
| * | K063632 | X-Force N30 Nephrostomy Balloon Dilation CatheterSummary page 1…ied C. Predicate Device Name: Trade Name: X-ForceTm N30 Nephrostomy Balloon Dilation Catheter # K051316 and K063632 D. Device Description: The Bard X-ForceTm Nephrostomy catheter is composed of a dual lumen shaft with inflation and guid… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | 2020 | 0 |
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 3 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K201165 (Coloplast Corp., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051316.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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/K080944 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080944: X-Force Nephrostomy Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080944
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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