Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

BTG — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

172 daysmedian FDA review time

473 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251279	Disposable Cytology Brush BC-202D/203D Series	Olympus Medical Systems Corporation	2025-06-12	49	0
K182927	Pulmonary Cytology Brush	Hobbs Medical, Inc.	2020-02-07	473	2
K190293	Single Use Cytology Brush BC-205D	Olympus Medical Systems Corp.	2019-08-02	172	0
K130357	SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH	Covidien, LLC	2013-11-06	266	0
K820771	MICROBIOLOGY SPECIMEN BRUSH	Mill-Rose Laboratory	1982-05-03	41	0
K780872	CYTOLOGY BRUSH	CooperVision, Inc.	1978-09-07	100	2

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda