510(k) · Cleared
Recalled · Class II · 2021Hobbs Medical Microbiology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hobbs Medical, Inc. · FDX Endoscopic Cytology Brush
Cleared on Aug 28, 1989 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Aug 28, 1989
- Review
- 103 days
- Class
- Class II
- Product code
- FDX
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2021 | Class II | Z-0711-2022 | No Marketing Application | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use. |
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K893729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K893729: Hobbs Medical Microbiology Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893729
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026