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

FZX — Predicate Candidate Screening

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

59 daysmedian FDA review time

130 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K914715	PARALLELING GUIDES	Implant Corp. of America	1994-02-16	852
K871413	CIVCO STEPPER	CIVCO Medical Instruments Co., Inc.	1987-07-14	97
K871503	BIOPSY NEEDLE GUIDE KIT, STERILE	Amedic USA	1987-07-10	84
K862564	A.C.L. GUIDE KIT	Aspen Laboratories, Inc.	1986-08-18	46
K854262	MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY	Meadox Surgimed, Inc.	1985-12-24	62
K852402	NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER	North American Instrument Corp.	1985-07-11	35
K842698	BRITISH SPINAL FUSION SET	Downs Surgical , Ltd.	1984-09-12	63
K841618	THREADING TUBE	Plastafil, Inc.	1984-08-27	130
K841619	DRILL GUIDE	Plastafil, Inc.	1984-07-11	83
K841297	TECHMEDICA DRILL GUIDE	Techmedica, Inc.	1984-04-25	26
K840835	STRAITH DRAIN INSERTER	Surgical Technology Laboratories, Inc.	1984-04-23	59
K834350	ACUFEX DREZ COMMUNICATING DRILL GUIDE	Acufex Microsurgical, Inc.	1984-03-19	97
K830720	GRAF MENISCAL SUTURE SET	Acufex Microsurgical, Inc.	1983-06-16	100
K821618	DISPOSABLE NEEDLE HOLDERS	Medcare Products	1982-06-21	19
K810888	BOUNDARY TUBING HOLDERS	The Buckeye Cellulose Corp.	1981-04-23	21
K810788	SURGICAL TUBE HOLDER	The Urology Group	1981-04-17	25
K802093	GABBAY-FRATER SUTURE GUIDE	Howmedica Corp.	1980-09-26	24
K792468	FEEDING TUBE PLACEMENT STYLET	Biosearch Medical Products, Inc.	1979-12-27	24
K790872	ENTERIC TUBE GUIDE	Biosearch Medical Products, Inc.	1979-05-23	16

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