510(k) · Cleared
ClearedCook Ireland Echobrush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · FDX Endoscopic Cytology Brush
Cleared on Oct 11, 2005 as substantially equivalent to K934356 (Wilson-Cook Medical, Inc., 1994) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Oct 11, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- FDX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896318 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K052279 | Cook Ireland Echobrush | Cook Ireland, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K934356 | Wilson-Cook GI Aspiration NeedleSummary page 1…, For Endoscope 21 CFR§ 876.1500, IFDX Predicate Device: Wilson-Cook GI Aspiration Needle, K934356 Wilson-Cook Biliary Cytology Brush, K040324 Intended Use:… | 1994 |
| * | K040324 | Wilson-Cook Double Lumen Biliary Cytology BrushSummary page 1…icate Device: Wilson-Cook GI Aspiration Needle, K934356 Wilson-Cook Biliary Cytology Brush, K040324 Intended Use: The EchoBrush TM is used to sample targeted… | 2004 |
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K934356.
How does its category compare?
All FDX devicesFDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 EchoBrush TM is used to sample targeted submucosal gastrointestinal lesions through
the accessory channel of an ultrasound endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052279 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052279: Cook Ireland Echobrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052279
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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