Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

GEE · Predicate Candidate Screening

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

32 daysmedian FDA review time

91 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K854003	STERILE SOFT TISSUE BIOPSY NEEDLE	Co-Medical, Inc.	1985-10-18	18
K841008	BIOPSY PUNCH, VARIOUS	Premier Dental Products Co.	1984-06-08	91
K822490	DEFLECTING CYTOLOGY BRUSH	Van-Tec, Inc.	1982-09-14	27
K820259	STERILE CYTOLOGY BRUSHES	American Endoscopy, Inc.	1982-03-05	32
K812694	WHISK-R	Medi-Spec	1981-10-26	34
K801304	CAMLOC SYRINGE BIOPSY KIT	Johannah Medical Services, Inc.	1980-06-17	9
K792316	TROTEX II SCREW NEEDLE BIOPSY INSTR. SET	Ursus Konsult AB	1979-12-18	32

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