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

IZZ — Predicate Candidate Screening

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

45 daysmedian FDA review time

157 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K971452	MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE	Siemens Medical Solutions USA, Inc.	1997-05-14	23	7
K952701	MED-TRON SPECT IMAGING TABLE	Med-Tron Products, Inc.	1995-07-06	23	0
K951315	CATHETERIZATION TABLE KS-60	Shimadzu Medical Systems	1995-05-11	49	0
K951053	ANGIOREX CAT-350B	Toshiba America Medical Systems, In.C	1995-04-06	30	0
K943926	RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE	Philips Medical Systems (Cleveland), Inc.	1994-11-28	108	0
K930273	ALPHA	Raymax Medical Corp.	1993-07-13	175	0
K924444	B-4 FOUR-WAY RADIOGRAPHIC TABLE	Control-X, Inc.	1993-02-05	157	0
K925174	SHIMADZU RADIOGRAPHIC TABLE BK-100	Shimadzu Medical Systems	1992-11-27	45	0
K921501	DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004	Biodan Medical Systems, Ltd.	1992-05-15	45	0
K920732	CATHERIZATION KS-50	Shimadzu Medical Systems	1992-04-16	58	0
K915413	CAT-250B	Toshiba America Medical Systems, In.C	1991-12-19	15	0
K912516	CLASSIC-II 4-WAY HORIZONTAL TABLE CAT.# T-9111	Continental X-Ray Corp.	1991-11-19	166	0
K912474	CLASSIC 4-WAY ELEVATING TABLE	Continental X-Ray Corp.	1991-09-16	105	0
K903921	MTE-T RADIOGRPHIC/TOMOGRAPHIC ELEVATING TABLE	Imt America, Inc.	1990-12-04	102	0
K896665	EXT-600 TABLE, RADIOGRAPHIC, ELEVATING	Rms Div.	1990-01-22	56	0
K894188	GX-ELEVATOR	Gendex Corp.	1989-10-03	109	0
K893452	EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM	Warner-Lambert Co.	1989-06-22	50	0
K891403	HUGH YOUNG II UROLOGICAL TABLE	Mallinckrodt Group, Inc.	1989-06-22	100	0
K893129	CXC FFT-1 NON-TILT STAT RADIO XRAY TAB 4 WA FL TAB	Continental X-Ray Corp.	1989-06-01	37	0
K884930	COMPAX MODEL 40, 400, 400T	General Electric Co.	1988-12-22	27	1
K883974	TANGENT II	Fischer Imaging Corp.	1988-10-20	30	0
K861940	RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T	D&R X-Ray Products, Inc.	1986-05-29	9	0
K840156	PROTECTA COAT SPONGES	Alimed, Inc.	1984-03-23	70	0
K834494	SPECTRUM X-RAY CORP	Spectrum X-Ray Corp.	1984-02-21	69	0
K827928	VRT TABLE	General Electric Co.	1982-09-29	43	0
K792169	HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING	Bennett X-Ray Corp.	1979-12-10	42	0
K772283	RX PEDESTAL TABLE	General Electric Co.	1977-12-15	3	0
K771601	X-RAY REMOTE CONTROL TABLE	Toshiba Medical Systems	1977-09-20	32	0
K761339	RADIAL TRAVEL SPEC. PROCEDURES TABLE	Xre Corp.	1977-01-05	9	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