510(k) · Decided
DecidedStonetome Stone Removal Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LQR Dislodger, Stone, Biliary
Cleared on Jul 25, 2019 as substantially equivalent to K946358 (Boston Scientific Corp, 1995) after a 22-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 25, 2019
- Review
- 22 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946358 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946358 Endoscopic Biliary CatheterBoston Scientific Corp · 1995 · Recalled
- This deviceK191789 Stonetome Stone Removal DeviceBoston Scientific Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946358 | Endoscopic Biliary Catheter | Boston Scientific Corp | 1995 | 9 |
| 0 (this device) | K191789 | Stonetome Stone Removal Device | Boston Scientific Corporation | 2019 | — |
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 |
|---|---|---|---|
| * | K946358 | Endoscopic Biliary CatheterSummary page 4…redicate Device Trade Name: Endoscopic Biliary Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K946358 Common Name: Biliary Stone Dislodger Product Code: LQR Device Class and Panel: Class… | 1995 |
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?
- Its one ancestor has a recall.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Stonetome Stone Removal Device is indicated for use in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography (ERCP), transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191789: Stonetome 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/K191789
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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