510(k) · Cleared
ClearedSingle Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aomori Olympus Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 14, 2003 as substantially equivalent to K962925 (Olympus America, Inc., 1996) after a 29-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Nov 14, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904669 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK904669 Balloon CathetersOlympus Corp. · 1991
- 1 generation backK962925 Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc. · 1996 · Recalled
- This deviceK033333 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 ownK091495 Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation · 2009 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K091495Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904669 | Balloon Catheters | Olympus Corp. | 1991 | — |
| −1 | K962925 | Olympus B-5/B-7 Seriesballoon Catheter | Olympus America, Inc. | 1996 | 5 |
| 0 (this device) | K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B | Aomori Olympus Co., Ltd. | 2003 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K962925 | Olympus B-5/B-7 Seriesballoon CatheterSummary page 1…FR Number : 876.1500 5. Classification Panel : 78 6. Product Code : FGE, KOG C. PREDICATE DEVICE INFORMATION B-5 /B-7 series Balloon Catheter K962925 D. DEVICE DESCRIPTION The subject device(s) is a balloon catheter that has a triple-lumen catheter and a multiple sizing ba… | 1996 |
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 |
|---|---|---|---|
| K091495 | Single Use 3-Lumen Extraction Balloon V, Model V… | 2009 | 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 12 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K091495 (Olympus Medical Systems Corporation, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K962925.
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?
These instruments have been designed to be used with Olympus endoscopes to inject
contrast media into the biliary or pancreatic tract. They can also be used for retrieval of
biliary or pancreatic stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033333: Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033333
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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