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

GDF — Predicate Candidate Screening

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

71 daysmedian FDA review time

192 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K031173	NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069,	Needle Tech Products, Inc.	2003-07-23	100	0
K950311	GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WIT	Global Medical Products, Ltd.	1995-05-26	130	0
K950007	SURGICAL INSTRUMENT GUIDE	United States Surgical, A Division of Tyco Healthc	1995-03-15	71	0
K945124	BREAST LESION LOCALIZATION NEEDLE	Promex, Inc.	1994-11-22	34	0
K944942	BREAST LESION LOCALIZATION NEEDLE	Promedical , Ltd.	1994-11-04	28	0
K935538	BAUER TEMNO COAXIAL NEEDLE	Bauer Medical, Inc.	1994-02-22	98	0
K935457	LOCALIZATION WIRE OR MARKER - SURGICAL	Bip USA, Inc.	1994-02-17	97	1
K923840	NEEDLE-GRABBER	Guardian Angel Products, Inc.	1993-07-13	347	0
K923835	THE ELEVENTH FINGER	Guardian Angel Products, Inc.	1993-07-09	343	0
K925875	HORIZONTAL NEEDLE GUIDE ATTACHMENT	Bip USA, Inc.	1993-04-06	138	0
K924270	BREAST LESION LOCALIZATION NEEDLE	Core Medical, Inc.	1992-09-23	30	0
K923120	MICROGUIDE LESION MARKING SYSTEM	Angiodynamics, Div. E-Z-Em, Inc.	1992-09-01	67	0
K914941	SIMON BREAST LESION LOCALIZATION NEEDLE	Manan Medical Products, Inc.	1992-05-14	192	0
K920816	PERCUGUIDE LESION MARKING	E-Z-Em, Inc.	1992-04-21	75	0
K904172	ACCUPLACE (TM)	Dlp, Inc.	1990-11-21	71	4
K900903	KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE	Milex Products, Inc.	1990-05-03	65	0
K890211	MICROSURGICAL NEEDLE HOLDERS	Kinetic Medical Products	1989-01-27	9	0
K890229	SURGICAL NEEDLE HOLDERS	Kinetic Medical Products	1989-01-27	9	0
K890228	SURGICAL NEEDLE GUIDE	Kinetic Medical Products	1989-01-27	9	0
K882036	WILLIAMS ACS MARKER NEEDLE	Buckman Co., Inc.	1988-07-27	72	0
K864551	BIOPSY ADAPTER #H4221BG	General Electric Co.	1986-12-23	34	0
K863090	PERCU GUIDE I (LOOP TYPE)	E-Z-Em, Inc.	1986-08-29	16	0
K861050	BIOPSY ADAPTER H4222W	General Electric Co.	1986-04-02	14	0
K845038	BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT	Ranfac, Corp.	1985-03-11	74	0
K832978	MENISCAL SUTURE GUN	Instrument Makar, Inc.	1983-12-12	101	0
K821354	CONPHAR MAYO HEGAR NEEDLE HOLDER	Conphar, Inc.	1982-06-03	29	0
K821289	MAYO-HEGAR NEEDLE HOLDER	Conphar, Inc.	1982-06-03	30	0
K821295	OLSEN HEGAR NEEDLE HOLDERS	Conphar, Inc.	1982-06-03	30	0

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