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

DWO — Predicate Candidate Screening

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

46 daysmedian FDA review time

89 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K933364	PROMED BIOPSY NEEDLE	Vlv Associates, Inc.	1994-02-15	221
K921418	ULTRA-CORE BIOPSY NEEDLES	Medical Device Technologies, Inc.	1992-06-19	87
K913815	AUTOMATED BIOPSY DEVICE, MODIFICATION	Hart Enterprises, Inc.	1991-10-30	65
K890925	MANAN BONE MARROW BIOPSY NEEDLE	Manan Medical Products, Inc.	1989-04-11	46
K885145	MEDSURG GREENE NEEDLE	Medsurg Industries, Inc.	1989-03-14	89
K885149	NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE	Hart Enterprises, Inc.	1989-01-26	42
K882013	SOFT TISSUE BIOPSY DEVICE	Ocean Medical Products, Ltd.	1988-06-15	33
K874585	ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE	Angiomed U.S., Inc.	1987-12-02	23
K872597	FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE	Dianon Systems, Inc.	1987-07-28	26
K853312	ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES	Argon Medical Corp.	1985-09-12	36
K820269	RNG SERIES ULTRASOUND NEEDLE/CATH. GDS	CIVCO Medical Instruments Co., Inc.	1982-03-23	49

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