510(k) · Cleared
ClearedCytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · FDX Endoscopic Cytology Brush
Cleared on Mar 5, 2018 as substantially equivalent to K896318 (Wilson-Cook Medical, Inc., 1990) after a 181-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Mar 5, 2018
- Review
- 181 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896318 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 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) | K172663 | Cytology Brush | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +1 | K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 5…The Cytology Brush is used to collect cells from the bronchi and upper and lower gastrointestinal tracts. 4. Identification of Predicate Device 510(k) Number: K896318 Product Name: Wilson-Cook Cytology Brush Manufacturer: Wilson-Cook Medical, Inc. 5. Indications for Use The Cytology Br… | 1990 |
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 |
|---|---|---|---|
| K220063 | Single Use Cytology Brush | 2022 | 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?
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Cytology Brush is used to collect cells from the bronchi and upper and lower gastrointestinal tracts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172663: 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/K172663
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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