510(k) · Cleared

Cleared

Disposable Cytology Brush BC-202D/203D Series

K251279510(k) TraditionalCleared Jun 12, 202549-day reviewClass II21 CFR 874.4680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Olympus Medical Systems Corporation · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)

Cleared on Jun 12, 2025 as substantially equivalent to K190293 (Olympus Medical Systems Corp., 2019) after a 49-day review. Its family tree reaches back 2 generations to 1978.

Decided: Jun 12, 2025
Review: 49 days
Class: Class II
Product code: BTG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K780872 (1978). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK780872 Cytology BrushCooperVision, Inc. · 1978 · Recalled
1 generation backK190293 Single Use Cytology Brush BC-205DOlympus Medical Systems Corp. · 2019
This deviceK251279 Disposable Cytology Brush BC-202D/203D SeriesOlympus Medical Systems Corporation · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K780872	Cytology Brush	CooperVision, Inc.	1978	2
−1	K190293	Single Use Cytology Brush BC-205D	Olympus Medical Systems Corp.	2019	—
0 (this device)	K251279	Disposable Cytology Brush BC-202D/203D Series	Olympus Medical Systems Corporation	2025	—

FIG. 1 — Lineage of K251279, 1978–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K190293	Single Use Cytology Brush BC-205D Summary page 5 …510(k) Submitter 510(k) No. Single Use Cytology Brush BC-205D Olympus Medical Systems Corporation K190293 Intended Use/Indications for Use The DISPOSABLE CYTOLOGY BRUSH BC-202D/203D Series is intended to be used to collect tissue spe…	Olympus Medical Systems Corp.	2019	—

Also cleared against K190293: 2 other devices →

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 47 years and passes through 3 companies; a new generation was cleared every 40.9 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K190293.

How does its category compare?

All BTG devices

BTG Brush, Biopsy, Bronchoscope (Non-Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · BTG

1in 2025

2007high 1 (2013) · low 0 (2007)2026

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

2007high 25 (2008) · low 0 (2021)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	MAUDE reports
2007	0	—	3
2008	0	—	25
2009	0	—	4
2010	0	—	1
2011	0	—	1
2012	0	—	9
2013	1	—	1
2014	0	—	5
2015	0	—	3
2016	0	—	8
2017	0	—	8
2018	0	—	8
2019	1	—	8
2020	1	—	11
2021	0	—	0
2022	0	—	4
2023	0	—	1
2024	0	—	8
2025	1	—	9
2026	0	—	—

What is it indicated for?

The DISPOSABLE CYTOLOGY BRUSH BC-202D/203D Series is intended to be used to collect tissue specimens in the tracheobronchial tree in combination with a bronchoscope.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K251279 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251279: Disposable Cytology Brush BC-202D/203D Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251279

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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