510(k) · Cleared
ClearedTri-EX Extraction Balloon with Multiple Sizing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on Feb 27, 2004 as substantially equivalent to K953951 (Wilson-Cook Medical, Inc., 1995) after a 37-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.
- Decided
- Feb 27, 2004
- Review
- 37 days
- Class
- Class II
- Product code
- GCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953951 (1995). 10 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995 · Recalled
- This deviceK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK170292 Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK200173 Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK063677 Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007
- Descendant · 3 generations on · 1 of its ownK210660 Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK253013 Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K170292Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. · 2017 · cites it directly6descendants
- K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020 · 2 generations on3descendants
- K063677Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007 · cites it directly2descendants
- K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021 · 3 generations on1descendant
- K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | 1 |
| 0 (this device) | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| +1 | 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 | K063677 | Fusion Quattro Extraction Balloon XL | Wilson-Cook Medical, Inc. | 2007 | — |
| +3 | K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021 | — |
| +3 | K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K953951 | Wilson-Cook Triple Lumen Balloon Stone ExtractorSummary page 1…21 CFR § 876.5010 78 GCA PREDICATE DEVICES: Wilson-Cook Triple Lumen Balloon Stone Extractor (k953951) Wilson-Cook's Tri-Ex Extraction Balloon with INTENDED USE:… | 1995 |
What descends from it? (10)
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?
- Its one ancestor has a recall.
- Of its descendants, K170292 (Wilson-Cook Medical, Inc., 2017) has gone furthest, with 6 descendants of its own.
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.
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 Tri-Ex Extraction Balloon with Multiple sizing is used for endoscopic removal of stones in the biliary system and for contrast injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040129 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040129: Tri-EX Extraction Balloon with Multiple Sizing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040129
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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