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

I.Z.I. Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

280 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K022074	SPHERZ	I.Z.I. Corp.	2002-08-13	48	25
K014022	MRI LINE MARKER	I.Z.I. Corp.	2002-03-04	88	1
K003736	MRI LINE MARKER	I.Z.I. Corp.	2001-01-18	45	0
K994117	MR ENHANCER	I.Z.I. Corp.	2000-02-04	60	0
K993742	SUPER TISSUE	I.Z.I. Corp.	2000-02-02	90	0
K930752	CT/MRI TOPOGRAPHIC MARKER	I.Z.I. Corp.	1993-11-19	280	0
K922287	E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS	I.Z.I. Corp.	1992-10-16	154	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