510(k) · Cleared
ClearedMicrobiology Specimen Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mill-Rose Laboratory · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Cleared on May 3, 1982 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 3, 1982
- Review
- 41 days
- Class
- Class II
- Product code
- BTG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK820771 Microbiology Specimen BrushMill-Rose Laboratory · 1982
- Descendant · cites it directly · 4 of its ownK960880 Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996
- Descendant · 2 generations on · 3 of its ownK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- Descendant · 3 generations on · 1 of its ownK050889 Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · 4 generations on · 0 of its ownK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K960880Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996 · cites it directly4descendants
- K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000 · 2 generations on3descendants
- K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005 · 3 generations on1descendant
- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · 3 generations on1descendant
- K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820771 | Microbiology Specimen Brush | Mill-Rose Laboratory | 1982 | — |
| +1 | K960880 | Mill-Rose Blind Microbiology Brush | Mill-Rose Laboratory | 1996 | — |
| +2 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| +3 | K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | 2005 | — |
| +3 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +4 | K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
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 BTG? 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 BTG device
- #1 K251279 Disposable Cytology Brush BC-202D/203D Seriesscore 9.8 · 2 generations · no Class I recall
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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960880 | Mill-Rose Blind Microbiology Brush | 1996 | 4 |
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?
- Of its descendants, K960880 (Mill-Rose Laboratory, 1996) has gone furthest, with 4 descendants of its own.
How does its category compare?
All BTG devicesBTG Brush, Biopsy, Bronchoscope (Non-Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTG
Too few BTG 510(k)s in any year since 2007 to give a median.
Recalls per year · BTG
No recall names BTG since 2007.
Adverse event reports per year · BTG
9in 2025
MAUDE reports naming product code BTG, 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 | 3 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K820771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820771: Microbiology Specimen Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820771
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026