510(k) · Cleared
ClearedFusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
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 Nov 14, 2019 as substantially equivalent to K171573 (Wilson-Cook Medical, Inc., 2017) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Nov 14, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896318 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK896318 Wilson-Cook Cytology BrushesWilson-Cook Medical, Inc. · 1990
- 3 generations backK040324 Wilson-Cook Double Lumen Biliary Cytology BrushWilson-Cook Medical, Inc. · 2004
- 2 generations backK171573 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2017
- 1 generation backK181317 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019
- This deviceK192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK250993 Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896318 | Wilson-Cook Cytology Brushes | Wilson-Cook Medical, Inc. | 1990 | — |
| −3 | K040324 | Wilson-Cook Double Lumen Biliary Cytology Brush | Wilson-Cook Medical, Inc. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Wilson-Cook Medical, Inc. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K171573 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushSummary page 4…1 CFR §876.1500, FDX, Class II Predicate Devices: Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared December 29, 2018 (k171573) Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared February… | 2017 |
| * | K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushSummary page 4…December 29, 2018 (k171573) Fusion Cytology Brush/ CytoMax II Double Lumen Cytology Brush cleared February 8, 2019 (k181317) Intended Use: Used for collection of cells in the biliary system. Device Description: The Fusion Cytology Brush and CytoMax II D… | 2019 |
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 |
|---|---|---|---|
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | 2025 | 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 29 years and passes through 1 company; a new generation was cleared every 13.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250993 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171573.
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Used for collection of cells in the biliary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192908: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192908
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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