510(k) · Cleared
Recalled · Class II · 2025Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL Retrieval Ballons Model M005470
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 Aug 23, 2010 as substantially equivalent to K041606 (Boston Scientific Corp, 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 23, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K931619 (1993). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931619 Microvasive Extractor, Retrieval Balloon CatheterBoston Scientific Corp · 1993
- This deviceK102082 Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval…Boston Scientific Corp · 2010
- Descendant · cites it directly · 1 of its ownK211021 Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon…Micro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 2 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 3 of 3 · See all- K211021Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire…Micro-Tech (Nanjing) Co., Ltd. · 2022 · cites it directly1descendant
- K253132Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · 2 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 |
|---|---|---|---|---|---|
| −1 | K931619 | Microvasive Extractor, Retrieval Balloon Catheter | Boston Scientific Corp | 1993 | — |
| 0 (this device) | K102082 | Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons… | Boston Scientific Corp | 2010 | — |
| +1 | K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /… | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +2 | K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K041606 | Extractor RX Retrieval BalloonSummary page 1…ssification: Class H1 3. Predicate Device: Trade Name: ExtractorTm 1RX Retrieval Balloon Manufacturer and Clearance Number: Boston Scientific Corporation, K04 1606 Classification Name: Endoscopic Biliary Stone Retrieval Balloon Catheter Regulation Number: 876.50 10 Produc… | 2004 |
| * | K931619 | Microvasive Extractor, Retrieval Balloon CatheterSummary page 1…E Classification: Class H Trade Name: Endoscopic Biliary Stone Retrieval Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K93 1619 Classification Name: Catheter, Biliary, Surgical Regulation Number: 876.5010 Product Code: GCA Classi… | 1993 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class II | Z-2618-2025 | Process control | The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. |
| Apr 27, 2015 | Class II | Z-1941-2015 | Employee error | One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. |
| Dec 18, 2013 | Class II | Z-0710-2014 | Process control | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size |
| Dec 18, 2013 | Class II | Z-0711-2014 | Process control | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size |
| Dec 18, 2013 | Class II | Z-0712-2014 | Process control | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2010, this device’s year, is highlighted.
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?
The Extractor Pro Retrieval Balloon Catheters are 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/K102082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102082: Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL Retrieval Ballons Model M005470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102082
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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