510(k) · Cleared
ClearedExtractor RX Retrieval Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 7, 2004 after a 22-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK041606 Extractor RX Retrieval BalloonBoston Scientific Corp · 2004
- Descendant · cites it directly · 3 of its ownK102082 Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval…Boston Scientific Corp · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK211021 Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon…Micro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK253132 Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK131642 RSH Biliary Stone Removal DeviceRsh, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K102082Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL…Boston Scientific Corp · 2010 · cites it directly3descendants
- K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire…Micro-Tech (Nanjing) Co., Ltd. · 2022 · 2 generations on1descendant
- K253132Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K131642RSH Biliary Stone Removal DeviceRsh, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041606 | Extractor RX Retrieval Balloon | Boston Scientific Corp | 2004 | — |
| +1 | K102082 | Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons… | Boston Scientific Corp | 2010 | 5 |
| +2 | K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /… | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +3 | K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
| +1 | K131642 | RSH Biliary Stone Removal Device | Rsh, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | — | Extractor RX Retrieval Balloon Named without a submission number | |
| * | — | Boston Scientific Extractor RX Retrieval Catheter Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K102082 (Boston Scientific Corp, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
Indicated for use endoscopically to remove stones from the biliary system, or 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/K041606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041606: Extractor RX Retrieval Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041606
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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