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

IZG — Predicate Candidate Screening

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

155 daysmedian FDA review time

462 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K960082	DISCOGRAPHY KIT	Spinal Specialties, Inc.	1996-03-21	70
K960146	G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY	GE Medical Systems	1996-02-27	42
K913436	PXI PNEUMATIC COMPRESSION PADDLE	Brotherston/Pxi	1992-11-05	462
K920393	MU125M MOBILE X-RAY SYSTEM	Shimadzu Medical Systems	1992-04-06	67
K910503	DISCOGRAPHY KIT	B. Braun of America, Inc.	1991-10-07	244
K903808	AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT	Advanced Med/Surg, Inc.	1991-01-22	155
K892659	ELECTRODELCA	Oldelft Corp. of America	1989-11-21	222

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