510(k) · Cleared
Recalled · Class II · 2021Olympus B-5/B-7 Seriesballoon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 25, 1996 as substantially equivalent to K904669 (Olympus Corp., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 25, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904669 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904669 Balloon CathetersOlympus Corp. · 1991
- This deviceK962925 Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK033333 Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003
- Descendant · cites it directly · 0 of its ownK250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter…Olympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK091495 Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation · 2009 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K033333Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003 · cites it directly1descendant
- K250409Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable…Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K091495Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904669 | Balloon Catheters | Olympus Corp. | 1991 | — |
| 0 (this device) | K962925 | Olympus B-5/B-7 Seriesballoon Catheter | Olympus America, Inc. | 1996 | — |
| +1 | K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B | Aomori Olympus Co., Ltd. | 2003 | — |
| +1 | K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q)… | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K091495 | Single Use 3-Lumen Extraction Balloon V, Model V… | Olympus Medical Systems Corporation | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K904669 | Balloon CathetersSummary page 1…Usual Name: Balloon Catheter Classification Name: EndoscopeandAccessories Predicate Devices: OlympusB5/B7Biliary BalloonCatheter(K904669) Submitted By: Mr. Barry Sands (Contact Person) OlympusAmericaInc.… | 1991 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-0962-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0963-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0964-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0965-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0961-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The B5-2Q/B5-2LA and B7-2Q/B7-2LA Balloon Catheters are to be used for biliary or pancreatic stone removal and dye injection associated with ERCP.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962925: Olympus B-5/B-7 Seriesballoon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962925
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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