510(k) · Cleared
ClearedLemaitre Biliary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascutech, Inc. · LQR Dislodger, Stone, Biliary
Cleared on Jan 12, 2000 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 12, 2000
- Review
- 134 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
The LeMaitre Biliary Catheter is indicated for the removal of stones and ductal debris.
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/K992941 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992941: Lemaitre Biliary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992941
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026