510(k) · Cleared
ClearedStone Retrieval Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anrei Medical (Hangzhou) Co., Ltd. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on Apr 27, 2021 as substantially equivalent to K200173 (Hangzhou AGS MedTech Co., Ltd., 2020) after a 54-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Apr 27, 2021
- Review
- 54 days
- Class
- Class II
- Product code
- GCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953951 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995 · Recalled
- 3 generations backK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- 2 generations backK170292 Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017
- 1 generation backK200173 Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020
- This deviceK210660 Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232752 Stone Extraction Balloon…Jiangsu Vedkang Medical Science and Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232752Stone Extraction Balloon…Jiangsu Vedkang Medical Science and Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | 1 |
| −3 | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| −2 | K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017 | — |
| −1 | K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| 0 (this device) | K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| +1 | K232752 | Stone Extraction Balloon… | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K200173 | Stone Retrieval BalloonSummary page 5…is used to insert the guide wire rapidly. EO sterilization and use for single use only. 4. Identification of Predicate Device(s) 510(k) Number: K200173 Product Name: Stone Retrieval Balloon Manufacturer: Hangzhou AGS MedTech Co., Ltd. 5. Comparison of Tech… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232752 | Stone Extraction Balloon… | 2024 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K232752 (Jiangsu Vedkang Medical Science and Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200173.
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. 2021, 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 as stated in the FDA summary.
https://510kreport.com/device/K210660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210660: Stone Retrieval Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210660
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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