510(k) · Cleared
Recalled · Class II · 2021Single Use 3-Lumen Extraction Balloon V, Model V B-V233P-a,B-V233P-B,B-V433P-a,B-V433P-B, BV243Q-a, B-V243Q-B, B-V443Q-a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · LQR Dislodger, Stone, Biliary
Cleared on Sep 3, 2009 as substantially equivalent to K033333 (Aomori Olympus Co., Ltd., 2003) after a 106-day review. Its family tree reaches back 3 generations to 1991. It has been recalled 3 times.
- Decided
- Sep 3, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- LQR
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904669 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK904669 Balloon CathetersOlympus Corp. · 1991
- 2 generations backK962925 Olympus B-5/B-7 Seriesballoon CatheterOlympus America, Inc. · 1996 · Recalled
- 1 generation backK033333 Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BAomori Olympus Co., Ltd. · 2003
- This deviceK091495 Single Use 3-Lumen Extraction Balloon V, Model V…Olympus Medical Systems Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904669 | Balloon Catheters | Olympus Corp. | 1991 | — |
| −2 | K962925 | Olympus B-5/B-7 Seriesballoon Catheter | Olympus America, Inc. | 1996 | 5 |
| −1 | K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B | Aomori Olympus Co., Ltd. | 2003 | — |
| 0 (this device) | K091495 | Single Use 3-Lumen Extraction Balloon V, Model V… | Olympus Medical Systems Corporation | 2009 | — |
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 LQR? 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 LQR device
- #1 K253056 Disposable Stone Extraction Basketscore 11.7 · 3 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 |
|---|---|---|---|
| * | K033333 | Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-BSummary page 2…Name: Balloon Catheter- * Manufacturer: Aomori Olympus Optical Co., Ltd. * 510(k) No. K033333 4 Device Description The Single Use 3-Lumen Extraction Balloon V, model B-V233P-A, B-V233P-B, B-V433P-A, B-V433P-B, B… | 2003 |
| † | K063677 | Fusion Quattro Extraction Balloon XL | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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-0968-2021 | 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-0966-2021 | 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-0967-2021 | 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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LQR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQR
248in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQR
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQR
111in 2025
MAUDE reports naming product code LQR, 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 | 1 | — | 0 | 23 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 3 | 28 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 50 |
| 2013 | 1 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 4 | 148 | 0 | 11 |
| 2018 | 3 | 248 | 0 | 43 |
| 2019 | 1 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 51 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 58 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 2 | — | 0 | 69 |
| 2025 | 1 | — | 0 | 111 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
These instruments have been designed to be used with Olympus endoscopes to. endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091495 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091495: Single Use 3-Lumen Extraction Balloon V, Model V B-V233P-a,B-V233P-B,B-V433P-a,B-V433P-B, BV243Q-a, B-V243Q-B, B-V443Q-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091495
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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