510(k) · Cleared
ClearedStone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Vedkang Medical Science and Technology Co., Ltd. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on Feb 26, 2024 as substantially equivalent to K210660 (Anrei Medical (Hangzhou) Co., Ltd., 2021) after a 171-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Feb 26, 2024
- Review
- 171 days
- Class
- Class II
- Product code
- GCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953951 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995 · Recalled
- 4 generations backK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- 3 generations backK170292 Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017
- 2 generations backK200173 Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020
- 1 generation backK210660 Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021
- This deviceK232752 Stone Extraction Balloon…Jiangsu Vedkang Medical Science and Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | 1 |
| −4 | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| −3 | K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017 | — |
| −2 | K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| −1 | K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| 0 (this device) | K232752 | Stone Extraction Balloon… | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024 | — |
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 GCA? 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 GCA device
- #1 K253013 Disposable Stone Retrieval Balloon Catheterscore 12.2 · 4 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 |
|---|---|---|---|
| * | K210660 | Stone Retrieval Balloon CatheterSummary page 6…n diameter is only 8.5mm, the operator can choose according to different clinical needs. EO sterilization and use for single use only. Predicate Device 510(k) Number: K210660 Trade Name: Stone Retrieval Balloon Catheter Common Name: Stone Retrieval Balloon Catheter Performance Data and Non-Clinical Te… | 2021 |
| † | K091495 | Single Use 3-Lumen Extraction Balloon V, Model V… | 2009 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All GCA devicesGCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GCA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GCA
Too few GCA 510(k)s in any year since 2007 to give a median.
Recalls per year · GCA
No recall names GCA since 2007.
Adverse event reports per year · GCA
24in 2025
MAUDE reports naming product code GCA, 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 | 6 |
| 2008 | 0 | — | 0 | 36 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 2 | — | 0 | 38 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 2 | — | 0 | 20 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is intended for endoscopic removal of biliary stones. The device is supplied sterile and intended for single 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/K232752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232752: Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232752
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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