510(k) · Cleared
ClearedWilson-Cook Double Lumen Biliary Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FDX Endoscopic Cytology Brush
Cleared on May 20, 2004 as substantially equivalent to K896318 (Wilson-Cook Medical, Inc., 1990) after a 100-day review. Its family tree reaches back 1 generation to 1990. 5 later devices descend from it.
- Decided
- May 20, 2004
- Review
- 100 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896318 (1990). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK896318 Wilson-Cook Cytology BrushesWilson-Cook Medical, Inc. · 1990
- This deviceK040324 Wilson-Cook Double Lumen Biliary Cytology BrushWilson-Cook Medical, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK181317 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK250993 Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK052279 Cook Ireland EchobrushCook Ireland, Ltd. · 2005
Most influential descendants
Showing 5 of 5 · See all- K171573Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2017 · cites it directly3descendants
- K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019 · 2 generations on2descendants
- K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019 · 2 generations on1descendant
- K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025 · 3 generations on0descendants
- K052279Cook Ireland EchobrushCook Ireland, Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896318 | Wilson-Cook Cytology Brushes | Wilson-Cook Medical, Inc. | 1990 | — |
| 0 (this device) | K040324 | Wilson-Cook Double Lumen Biliary Cytology Brush | Wilson-Cook Medical, Inc. | 2004 | — |
| +1 | K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2017 | — |
| +2 | K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2019 | — |
| +2 | K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019 | — |
| +3 | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K052279 | Cook Ireland Echobrush | Cook Ireland, Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2025 | 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 FDX? 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 FDX device
- #1 K250993 Single Use Cytology Brush V (BC-V600P-3010)score 11.7 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K896318 | Wilson-Cook Cytology BrushesSummary page 1…Cytology for Endoscope, Class II 21 CFR § 876.1500 78 FDX PREDICATE DEVICES: Wilson-Cook Cytology Brushes (k89631 8) Wilson-Cook's Double Lumen Biliary Cytology INTENDED USE: Bru… | 1990 |
What descends from it? (5)
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?
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDX
144in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDX
11in 2025
MAUDE reports naming product code FDX, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 37 |
| 2010 | 1 | — | 0 | 37 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 28 |
| 2013 | 0 | — | 0 | 45 |
| 2014 | 0 | — | 0 | 61 |
| 2015 | 1 | — | 0 | 62 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 2 | — | 0 | 44 |
| 2018 | 1 | — | 0 | 48 |
| 2019 | 4 | 144 | 0 | 67 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 1 | 19 |
| 2022 | 1 | — | 2 | 17 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Wilson-Cook Double Lumen Biliary Cytology Brush is intended for the collection of cells in the biliary system. The device is supplied sterile and intended for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040324: Wilson-Cook Double Lumen Biliary Cytology Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040324
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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