510(k) · Cleared
Recalled · Class II · 2025Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · LJE Catheter, Nephrostomy
Cleared on Feb 4, 2014 as substantially equivalent to K121614 (Boston Scientific Corp, 2012) after a 188-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Feb 4, 2014
- Review
- 188 days
- Class
- Class U
- Product code
- LJE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952968 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK952968 Dilatation Catheter, BalloonBoston Scientific Corp · 1995
- 1 generation backK121614 Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterBoston Scientific Corp · 2012 · Recalled
- This deviceK132383 Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation CatheterGyrus Acmi, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952968 | Dilatation Catheter, Balloon | Boston Scientific Corp | 1995 | — |
| −1 | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation Catheter | Boston Scientific Corp | 2012 | 3 |
| 0 (this device) | K132383 | Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter | Gyrus Acmi, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K121614 | Nephromax High Pressure Nephrostomy Baloon Dilatation CatheterSummary page 1…n Dilation Catheter Generic/Common Name: Balloon Dilation Catheter Predicate Devices Boston Scientific NephroMax High K121614 Pressure Balloon Dilation Catheter… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2025 | Class II | Z-0572-2026 | Process control | Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K121614.
How does its category compare?
All LJE devicesLJE Catheter, Nephrostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Gyrus ACMI Nepbro - EZDilate Nephrostomy Balloon Dilation Catheter is recommended for dilation of the nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132383: Gyrus Acmi Nephro - Ezdilate Nephrostomy Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132383
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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