510(k) · Cleared
ClearedSingle use stone retrieval balloons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Chuangxiang Medical Technology Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 6, 2026 as substantially equivalent to K211021 (Micro-Tech (Nanjing) Co., Ltd., 2022) after a 162-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 6, 2026
- Review
- 162 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K931619 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK931619 Microvasive Extractor, Retrieval Balloon CatheterBoston Scientific Corp · 1993
- 2 generations backK102082 Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval…Boston Scientific Corp · 2010 · Recalled
- 1 generation backK211021 Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon…Micro-Tech (Nanjing) Co., Ltd. · 2022
- This deviceK253132 Single use stone retrieval balloonsZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931619 | Microvasive Extractor, Retrieval Balloon Catheter | Boston Scientific Corp | 1993 | — |
| −2 | K102082 | Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons… | Boston Scientific Corp | 2010 | 5 |
| −1 | K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon /… | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| 0 (this device) | K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
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 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? (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 |
|---|---|---|---|
| * | K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire…Summary page 5…lation class: II Classification name: Biliary catheter and accessories Regulation number:876.5010 Product code: FGE 4. Predicative device identification 510(k) Number: K211021 Device Name: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible Product Code: FGE 5. De… | 2022 |
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 33 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2026, 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 Retrieval Balloon is indicated for use endoscopically to remove stones from biliary system, or to
facilitate injection of contrast medium while occluding the duct with the balloon. The device is for adult use
only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253132: Single use stone retrieval balloons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253132
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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