510(k) · Cleared
Recalled · Class II · 2011US Endoscopy Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FDX Endoscopic Cytology Brush
Cleared on Dec 23, 2010 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- FDX
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK103437 US Endoscopy Cytology BrushUnited States Endoscopy Group, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK142695 Cytosponge Cell Collection DeviceCovidien, LLC · 2014
- Descendant · 2 generations on · 3 of its ownK152794 Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK181020 Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK233142 EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024
- Descendant · 2 generations on · 0 of its ownK203450 EsophaCap Swallowable Cellular Retrieval Device (changed from…Capnostics, LLC · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K142695Cytosponge Cell Collection DeviceCovidien, LLC · 2014 · cites it directly4descendants
- K152794Cytosponge Cell Collection DeviceCovidien, LLC · 2016 · 2 generations on3descendants
- K181020Cytosponge Cell Collection DeviceCovidien, LLC · 2018 · 2 generations on2descendants
- K233142EndoSign® Cell collection device (ES-CYT-102)Cyted Limited · 2024 · 3 generations on0descendants
- K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103437 | US Endoscopy Cytology Brush | United States Endoscopy Group, Inc. | 2010 | — |
| +1 | K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014 | — |
| +2 | K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016 | 2 |
| +2 | K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018 | 1 |
| +3 | K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024 | — |
| +2 | K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) | Capnostics, LLC | 2021 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142695 | Cytosponge Cell Collection Device | 2014 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2011 | Class II | Z-2396-2012 | Nonconforming Material/Component | US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142695 (Covidien, LLC, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 disposable Cytology Brush is intended to be used to retrieve cytological cell samples in the gastrointestinal tract
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103437: US Endoscopy 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/K103437
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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