Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GZX — Predicate Candidate Screening

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

83 daysmedian FDA review time

118 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K932169	MICROSURGICAL INSTRUMENTS	American Russian Medical Services, Inc.	1993-07-20	76
K926048	CLARUS ENDOSCOPIC BALL PROBE	Clarus Medical Systems, Inc.	1993-04-07	127
K911932	J105 JAMES SURGICAL SYSTEM I/A PACK	O.R. Specialties, Inc.	1991-08-26	118
K890216	MICROSURGICAL KERATOME	Kinetic Medical Products	1989-02-16	29
K873934	RANGE OF CROCODILE ACTION INSTRUMENTS	Downs Surgical , Ltd.	1987-12-17	83
K873933	RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM	Downs Surgical , Ltd.	1987-12-17	83
K862971	MICRA MICROSURGICAL INSTRUMENTS	Cordis Corp.	1986-08-25	19
K853161	THE VICKERS STANDARD MICROSURGERY SET	Keeler Instruments, Inc.	1985-11-07	100
K853179	VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND	Keeler Instruments, Inc.	1985-11-07	100
K853180	VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED	Keeler Instruments, Inc.	1985-10-28	90
K853181	VICKERS ERGOMATIC MICROS INSTR-FINE R OR L HANDED	Keeler Instruments, Inc.	1985-10-28	90
K831071	UNIVERSAL INSTRU. SET FOR NEUROVASCULAR	Prothia USA, Inc.	1983-06-08	65
K810485	DUJOVNY MICROSURGICAL SCISSORS	American V. Mueller	1981-02-27	4

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