510(k) · Cleared
Recalled · Class II · 2024Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 8, 2018 as substantially equivalent to K143609 (Olympus Surgical Technologies America, 2015) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 1998. It has been recalled 13 times.
- Decided
- Mar 8, 2018
- Review
- 55 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974788 (1998). 6 ancestors in all, the oldest K910931 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- 3 generations backK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- 2 generations backK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- 1 generation backK143609 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterOlympus Surgical Technologies America · 2015
- This deviceK180086 Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| −3 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| −2 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| −1 | K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | Olympus Surgical Technologies America | 2015 | — |
| 0 (this device) | K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterSummary page 4…ic/Common Name: Balloon Dilation Catheter Predicate Devices Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter K143609 Boston Scientific CRE Dilatation Balloon K112994… | 2015 |
| * | K112994 | Cre Ditatation BallonSummary page 4…Devices Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter K143609 Boston Scientific CRE Dilatation Balloon K112994 6… | 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 |
|---|---|---|---|---|
| Sep 13, 2024 | Class II | Z-0225-2025 | Under Investigation by firm | Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box… |
| Nov 10, 2023 | Class II | Z-0935-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0933-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0936-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0939-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0941-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0942-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0934-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0938-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0944-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0937-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0940-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
| Nov 10, 2023 | Class II | Z-0943-2024 | Process control | Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180086: Gyrus ACMI – EZDilate 3-Stage Balloon 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/K180086
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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