510(k) · Cleared
Recalled · Class II · 2025Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LJE Catheter, Nephrostomy
Cleared on Sep 18, 2012 as substantially equivalent to K952968 (Boston Scientific Corp, 1995) after a 109-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 18, 2012
- Review
- 109 days
- Class
- Class U
- Product code
- LJE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952968 (1995). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK952968 Dilatation Catheter, BalloonBoston Scientific Corp · 1995
- This deviceK121614 Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp · 2012
- Descendant · cites it directly · 4 of its ownK130804 Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK171601 Ultraxx Nephrostomy Balloon CatheterCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK250910 Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK191061 Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190612 EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130804Uromax Ultra Balloon Dilatation CatheterBoston Scientific Corporation · 2013 · cites it directly4descendants
- K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated · 2018 · cites it directly1descendant
- K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc. · 2025 · 2 generations on0descendants
- K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc. · 2020 · 2 generations on0descendants
- K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952968 | Dilatation Catheter, Balloon | Boston Scientific Corp | 1995 | — |
| 0 (this device) | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter | Boston Scientific Corp | 2012 | — |
| +1 | K130804 | Uromax Ultra Balloon Dilatation Catheter | Boston Scientific Corporation | 2013 | 1 |
| +1 | K171601 | Ultraxx Nephrostomy Balloon Catheter | Cook Incorporated | 2018 | — |
| +2 | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | 2025 | — |
| +2 | K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020 | — |
| +2 | K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K952968 | Dilatation Catheter, BalloonSummary page 1…Catheter, Nephrostomy Classification Name: LIE - Catheter, Nephrostomy Pre-Amendment Premarket Notification: Boston Scientific, K952968 E. Device Description The NephroMax Balloon Catheter, styled after the Gruntzig technique, is a multiple lumen cathe… | 1995 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-2535-2025 | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could… |
| May 28, 2013 | Class II | Z-1673-2013 | Process control | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. |
| May 28, 2013 | Class II | Z-1672-2013 | Process control | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K130804 (Boston Scientific Corporation, 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 NephromaxTM High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121614: Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121614
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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