510(k) · Cleared
ClearedBalloon Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 15, 1991 after a 151-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 15, 1991
- Review
- 151 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK904669 Balloon CathetersOlympus Corp. · 1991
- Descendant · cites it directly · 3 of its ownK962925 Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc. · 1996 · Recalled
- Descendant · cites it directly · 2 of its ownK962901 Olympus B5-2C/B7-2C Balloon CatheterOlympus America, Inc. · 1996
- Descendant · 2 generations on · 1 of its ownK033333 Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003
- Descendant · 2 generations on · 0 of its ownK250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter…Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK250118 Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K962925Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc. · 1996 · cites it directly3descendants
- K962901Olympus B5-2C/B7-2C Balloon CatheterOlympus America, Inc. · 1996 · cites it directly2descendants
- K033333Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003 · 2 generations on1descendant
- K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K250118Disposable Balloon Catheter B5-2COlympus Medical Systems Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904669 | Balloon Catheters | Olympus Corp. | 1991 | — |
| +1 | K962925 | Olympus B-5/B-7 Seriesballoon Catheter | Olympus America, Inc. | 1996 | 5 |
| +1 | K962901 | Olympus B5-2C/B7-2C Balloon Catheter | Olympus America, Inc. | 1996 | — |
| +2 | K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B | Aomori Olympus Co., Ltd. | 2003 | — |
| +2 | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q)… | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K250118 | Disposable Balloon Catheter B5-2C | Olympus Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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?
- Of its descendants, K962925 (Olympus America, Inc., 1996) has gone furthest, with 3 descendants 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 | — |
https://510kreport.com/device/K904669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904669: Balloon Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904669
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026