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

IXJ — Predicate Candidate Screening

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

80 daysmedian FDA review time

229 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K964025	MITAYA ALUMINUM INTERSPACED X-RAY GRID	X-Ray Accessory Corp.	1997-06-13	249	0
K963893	FIBRE INTERSPACED X-RAY GRID	Smit Rontgen	1996-11-07	41	0
K962338	RADIOGRAPHIC GRID	Unidex Group, Inc.	1996-07-03	16	0
K954294	HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM S	Thermotrex Corp.	1996-02-02	141	0
K945697	SK S-RAY GRIDS	Seibu Techno Coproration	1995-01-31	75	0
K945327	JPI X-RAY GRID	Jpi America, Inc.	1995-01-20	80	0
K941626	GRIDGIL	Gilardoni S.P.A.	1994-05-13	39	0
K940309	X-RAY GRID (RADIOLOGICAL GRID)	J.P.I. Chicago Co.	1994-04-22	88	0
K926445	SOYEE ALUMINUM INTERSPACED X-RAY GRID	X-Ray Accessories Mfg. Co.	1993-04-07	105	0
K926261	JPI ALUMINUM INTERSPACED X-RAY GRID	Jpi, Inc.	1993-03-18	90	0
K925997	KODAK EKTASCAN SP CASSETTE	Eastman Kodak Company	1992-12-17	20	1
K901012	RADIOGRAPHIC GRID	Infab Corp.	1990-03-28	23	0
K883527	GRID/RADIOGRAPHIC	Umi, Inc.	1988-09-02	15	0
K854459	TBX MEDICAL X-RAY TABLE	Gendex Corp.	1986-02-12	98	0
K837776	AOR X-RAY ALIGMENT PAD	Zimmer, Inc.	1983-08-18	229	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