510(k) · Cleared
ClearedGyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 27, 2015 as substantially equivalent to K112994 (Boston Scientific Corporation, 2012) after a 98-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Mar 27, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K974788 (1998). 5 ancestors in all, the oldest K910931 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974788 Cre (TM) Balloon Dilatation CatheterBoston Scientific Corp · 1998
- 2 generations backK110833 Cre Balloon Dilatation CatheterBoston Scientific Corporation · 2011 · Recalled
- 1 generation backK112994 Cre Ditatation BallonBoston Scientific Corporation · 2012 · Recalled
- This deviceK143609 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterOlympus Surgical Technologies America · 2015
- Descendant · cites it directly · 0 of its ownK180086 Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K180086Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation CatheterGyrus Acmi, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974788 | Cre (TM) Balloon Dilatation Catheter | Boston Scientific Corp | 1998 | — |
| −2 | K110833 | Cre Balloon Dilatation Catheter | Boston Scientific Corporation | 2011 | 6 |
| −1 | K112994 | Cre Ditatation Ballon | Boston Scientific Corporation | 2012 | 6 |
| 0 (this device) | K143609 | Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter | Olympus Surgical Technologies America | 2015 | — |
| +1 | K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | Gyrus Acmi, Inc. | 2018 | 13 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K112994 | Cre Ditatation BallonSummary page 4…Catheter Generic/Common Name: Balloon Dilation Catheter Predicate Devices Boston Scientific CRE Dilatation Balloon K112994 K143609… | 2012 |
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 |
|---|---|---|---|
| K180086 | Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter | 2018 | 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 17 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K180086 (Gyrus Acmi, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K112994.
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. 2015, 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 EZDilate 3-Stage Balloon Dilatation Catheters are indicated for use in adult 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/K143609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143609: 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/K143609
Report an extraction error
Are you the manufacturer?
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