510(k) · Cleared
ClearedFusion Cytology Brush, CytoMax II Double Lumen 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 Dec 29, 2017 as substantially equivalent to K040324 (Wilson-Cook Medical, Inc., 2004) after a 213-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 29, 2017
- Review
- 213 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896318 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK896318 Wilson-Cook Cytology BrushesWilson-Cook Medical, Inc. · 1990
- 1 generation backK040324 Wilson-Cook Double Lumen Biliary Cytology BrushWilson-Cook Medical, Inc. · 2004
- This deviceK171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK181317 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK250993 Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019 · cites it directly2descendants
- K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019 · cites it directly1descendant
- K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896318 | Wilson-Cook Cytology Brushes | Wilson-Cook Medical, Inc. | 1990 | — |
| −1 | K040324 | Wilson-Cook Double Lumen Biliary Cytology Brush | Wilson-Cook Medical, Inc. | 2004 | — |
| 0 (this device) | K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2017 | — |
| +1 | K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | 2019 | — |
| +1 | K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019 | — |
| +2 | K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040324 | Wilson-Cook Double Lumen Biliary Cytology BrushSummary page 4…oscopic Cytology Brush Classification Name: Endoscope and accessories 21 CFR §876.1500, FDX, Class II Predicate Device: Wilson-Cook Double Lumen Biliary Cytology Brush, K040324, cleared May 20, 2004. Intended Use: The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collec… | 2004 |
What descends from it? (3)
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?
- The line of descent spans 27 years and passes through 1 company; a new generation was cleared every 14.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181317 (Wilson-Cook Medical, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K040324.
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collection of cells in the biliary system.
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/K171573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171573: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171573
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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