510(k) · Cleared
ClearedSingle Use Balloon Dilator Maxpasstm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 8, 2005 as substantially equivalent to K920361 (C.R. Bard, Inc., 1992) after a 130-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Jul 8, 2005
- Review
- 130 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920361 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920361 Bard Biliary Balloon DilatorsC.R. Bard, Inc. · 1992
- This deviceK050502 Single Use Balloon Dilator MaxpasstmOlympus Winter & Ibe GmbH · 2005
- Descendant · cites it directly · 1 of its ownK150142 Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015
- Descendant · 2 generations on · 0 of its ownK193039 Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 0 of its ownK143303 Single Use Biliary Balloon DilatorOlympus Medical Systems Corp. · 2015
Most influential descendants
Showing 3 of 3 · See all- K150142Single Use Balloon Dilator V (with Knife)Olympus Medical Systems Corp. · 2015 · cites it directly1descendant
- K193039Single Use Balloon Dilator V (with knife)Olympus Medical Systems Corp. · 2019 · 2 generations on0descendants
- K143303Single Use Biliary Balloon DilatorOlympus Medical Systems Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920361 | Bard Biliary Balloon Dilators | C.R. Bard, Inc. | 1992 | — |
| 0 (this device) | K050502 | Single Use Balloon Dilator Maxpasstm | Olympus Winter & Ibe GmbH | 2005 | — |
| +1 | K150142 | Single Use Balloon Dilator V (with Knife) | Olympus Medical Systems Corp. | 2015 | — |
| +2 | K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K143303 | Single Use Biliary Balloon Dilator | Olympus Medical Systems Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K013338 | Microvasive Rapid Exchange Biliary Balloon Dilation Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K920361 | Bard Biliary Balloon DilatorsSummary page 1…(K01 338 Boston Scientific Corporation) Bard biliary Balloon Dilators (K920361 C.R.Bard, Inc.)… | 1992 |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K150142 (Olympus Medical Systems Corp., 2015) has gone furthest, with 1 descendant of its own.
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.
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?
Single use balloon dilator Maxpass to be used in conjunction with Olympus endoscopes for dilating strictures of the biliary tree and the major papilla during endoscopic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050502: Single Use Balloon Dilator Maxpasstm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050502
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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