510(k) · Cleared
ClearedBronchi and Gastrointestinal Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical Inc./Cook Endoscopy · FDX Endoscopic Cytology Brush
Cleared on Jul 31, 2017 as substantially equivalent to K896318 (Wilson-Cook Medical, Inc., 1990) after a 60-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 31, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896318 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896318 Wilson-Cook Cytology BrushesWilson-Cook Medical, Inc. · 1990
- This deviceK171607 Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy · 2017
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) | K171607 | Bronchi and Gastrointestinal Cytology Brush | Wilson-Cook Medical Inc./Cook Endoscopy | 2017 | — |
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 4…e Class: Class II Review Panel: Gastroenterology-Urology Predicate Device Name: Wilson-Cook Cytology Brush 510(k) Number: K896318 Date: Cleared April 9, 1990 Device Description The Bronchi and Gastrointestinal Cytology Brush (subject device… | 1990 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K896318.
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?
This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171607 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171607: Bronchi and Gastrointestinal 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/K171607
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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