510(k) · Cleared
ClearedRSH Biliary Stone Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rsh, LLC · LQR Dislodger, Stone, Biliary
Cleared on Aug 7, 2013 as substantially equivalent to K102082 (Boston Scientific Corp, 2010) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 7, 2013
- Review
- 64 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K931619 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK931619 Microvasive Extractor, Retrieval Balloon CatheterBoston Scientific Corp · 1993
- 1 generation backK102082 Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval…Boston Scientific Corp · 2010 · Recalled
- This deviceK131642 RSH Biliary Stone Removal DeviceRsh, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931619 | Microvasive Extractor, Retrieval Balloon Catheter | Boston Scientific Corp | 1993 | — |
| −1 | K102082 | Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons… | Boston Scientific Corp | 2010 | 5 |
| 0 (this device) | K131642 | RSH Biliary Stone Removal Device | Rsh, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (2)
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 |
|---|---|---|---|
| * | K102082 | Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL…Summary page 1…Catheter, biliary, diagnostic (EGE) Classification Name: Biliary catheter and accessories (2 1 CER 876.5010, Class 2) Predicate(s): K102082/K041606 Extracto' T Retrieval Balloon catheters Trhe [(SH- Filiary Stone Removal Device is… | 2010 |
| * | K041606 | Extractor RX Retrieval BalloonSummary page 1…Catheter, biliary, diagnostic (EGE) Classification Name: Biliary catheter and accessories (2 1 CER 876.5010, Class 2) Predicate(s): K102082/K041606 Extracto' T Retrieval Balloon catheters Trhe [(SH- Filiary Stone Removal Device is used for… | 2004 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 17.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K102082.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The RSH Biliary Stone Removal Device is used for endoscopic removal of stones in the biliary system or for contrast injection while occluding the duct.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131642: RSH Biliary Stone Removal Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131642
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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