510(k) · Cleared
ClearedWilosn-Cook Biliary Dilation Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jun 25, 2004 as substantially equivalent to K935094 (Wilson-Cook Medical, Inc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 25, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K935094 (1995). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK935094 Balloon Dilation CatheterWilson-Cook Medical, Inc. · 1995 · Recalled
- This deviceK040800 Wilosn-Cook Biliary Dilation BalloonWilson-Cook Medical, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935094 | Balloon Dilation Catheter | Wilson-Cook Medical, Inc. | 1995 | 2 |
| 0 (this device) | K040800 | Wilosn-Cook Biliary Dilation Balloon | Wilson-Cook Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K935094 | Balloon Dilation CatheterSummary page 1…21 CFR § 876.5365 PREDICATE DEVICES: Wilson-Cook Quantum T.T.C.Dilation Balloon (k935094) Microvasive RX Biliary Balloon Dilation Catheter… | 1995 |
| * | K001338 | Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter Our reading of the summary gave K011338, FDA’s number for Oto-Cem (Ototech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Microvasive RX Biliary Balloon Dilation Catheter”. | 2000 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K935094.
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.
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 Wilson-Cook Biliary Dilation Balloon is intended to dilate strictures of the biliary tree. This device is supplied sterile and intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040800 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040800: Wilosn-Cook Biliary Dilation Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040800
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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