510(k) · Cleared
Recalled · 2009Endoscopic Biliary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LQR Dislodger, Stone, Biliary
Cleared on Apr 11, 1995 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Apr 11, 1995
- Review
- 102 days
- Class
- Class II
- Product code
- LQR
- Recalls
- 9
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK946358 Endoscopic Biliary CatheterBoston Scientific Corp · 1995
- Descendant · cites it directly · 0 of its ownK191789 Stonetome Stone Removal DeviceBoston Scientific Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K191789Stonetome Stone Removal DeviceBoston Scientific Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946358 | Endoscopic Biliary Catheter | Boston Scientific Corp | 1995 | — |
| +1 | K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K191789 | Stonetome Stone Removal Device | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2009 | Not classified | Z-1011-2009 | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. |
| Jan 8, 2009 | Not classified | Z-1012-2009 | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. |
| Jan 8, 2009 | Not classified | Z-1010-2009 | Packaging | The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated. |
| May 19, 2006 | Not classified | Z-1112-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
| May 19, 2006 | Not classified | Z-1113-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
| May 19, 2006 | Not classified | Z-1114-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
| May 19, 2006 | Not classified | Z-1110-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
| May 19, 2006 | Not classified | Z-1111-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
| May 19, 2006 | Not classified | Z-1109-06 | Other | Lack of assurance of sterility, as the sterile barrier may fail. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K191789 (Boston Scientific Corporation, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K946358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946358: Endoscopic Biliary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946358
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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