510(k) · Cleared
Recalled · 2005Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperVision, Inc. · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Cleared on Sep 7, 1978 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 7, 1978
- Review
- 100 days
- Class
- Class II
- Product code
- BTG
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK780872 Cytology BrushCooperVision, Inc. · 1978
- Descendant · cites it directly · 4 of its ownK190293 Single Use Cytology Brush BC-205DOlympus Medical Systems Corp. · 2019
- Descendant · 2 generations on · 1 of its ownK192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding…Olympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 0 of its ownK251279 Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK241679 Disposable Cytology Brush (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK212667 Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp. · 2021
Most influential descendants
Showing 5 of 5 · See all- K190293Single Use Cytology Brush BC-205DOlympus Medical Systems Corp. · 2019 · cites it directly4descendants
- K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp. · 2020 · 2 generations on1descendant
- K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K241679Disposable Cytology Brush (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025 · 2 generations on0descendants
- K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K780872 | Cytology Brush | CooperVision, Inc. | 1978 | — |
| +1 | K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | 2019 | — |
| +2 | K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | 2025 | — |
| +2 | K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025 | — |
| +3 | K212667 | Single Use Guide Sheath Kit-401, K-402 | Olympus Medical Systems Corp. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| K190293 | Single Use Cytology Brush BC-205D | 2019 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 8, 2005 | Not classified | Z-0376-06 | Other | The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing. |
| Dec 8, 2005 | Not classified | Z-0377-06 | Other | The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190293 (Olympus Medical Systems Corp., 2019) 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/K780872 · printed Nov 6, 2026
Cite this page
510(k) Report. “K780872: 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/K780872
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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