510(k) · Cleared
ClearedSingle Use Cytology Brush BC-205D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Cleared on Aug 2, 2019 as substantially equivalent to K780872 (CooperVision, Inc., 1978) after a 172-day review. Its family tree reaches back 1 generation to 1978. 4 later devices descend from it.
- Decided
- Aug 2, 2019
- Review
- 172 days
- Class
- Class II
- Product code
- BTG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780872 (1978). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK780872 Cytology BrushCooperVision, Inc. · 1978 · Recalled
- This deviceK190293 Single Use Cytology Brush BC-205DOlympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 1 of its ownK192164 Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding…Olympus Medical Systems Corp. · 2020
- Descendant · cites it directly · 0 of its ownK251279 Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK241679 Disposable Cytology Brush (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK212667 Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp. · 2021
Most influential descendants
Showing 4 of 4 · See all- K192164Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DROlympus Medical Systems Corp. · 2020 · cites it directly1descendant
- K251279Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K241679Disposable Cytology Brush (AF series)Alton (Shanghai) Medical Instruments Co., Ltd. · 2025 · cites it directly0descendants
- K212667Single Use Guide Sheath Kit-401, K-402Olympus Medical Systems Corp. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780872 | Cytology Brush | CooperVision, Inc. | 1978 | 2 |
| 0 (this device) | K190293 | Single Use Cytology Brush BC-205D | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K192164 | Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR | Olympus Medical Systems Corp. | 2020 | — |
| +1 | K251279 | Disposable Cytology Brush BC-202D/203D Series | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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 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? (1)
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 |
|---|---|---|---|
| * | K780872 | Cytology BrushSummary page 5…BC-205D 5.3 Predicate Device/Reference Device Information K number Product name Manufacturer Predicate device K780872 CYTOLOGY BRUSH COOPERVISION, INC. Reference device K171607 Bronchi and Wil… | 1978 |
| † | K171607 | Bronchi and Gastrointestinal Cytology Brush | 2017 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K192164 (Olympus Medical Systems Corp., 2020) has gone furthest, with 1 descendant 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. 2019, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190293: Single Use Cytology Brush BC-205D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190293
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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