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

IYB — Predicate Candidate Screening

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

45 daysmedian FDA review time

148 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K935123	SUPERSTAND 300	Wuestec Medical, Inc.	1996-03-27	881	0
K946261	MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5	Scott Imaging Intl., Inc.	1995-02-15	64	0
K941004	CTS SYSTEM	Acoma Medical Imaging, Inc.	1994-07-29	150	0
K941017	F/C/W TUBESTAND	Acoma Medical Imaging, Inc.	1994-07-29	148	0
K940442	MPR-814	Xri, Inc.	1994-06-09	128	0
K935004	MODEL ALPHA TS-2	Dpa Consulting, Inc.	1993-12-13	55	0
K933253	SUPERSTAND 3000	Wuestec Medical, Inc.	1993-08-16	45	0
K925716	BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC	Bennett X-Ray Corp.	1992-12-17	35	0
K925170	SHIMADZU X-RAY TUBE STAND BH-100 SERIES	Shimadzu Medical Systems	1992-12-07	55	0
K920727	CEILING TUBE SUPPORT CH-30X	Shimadzu Medical Systems	1992-04-16	58	0
K914944	BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC	Bennett X-Ray Corp.	1991-12-02	28	0
K914348	ER-1000 CATHERIZATION C-ARM SYSTEMS	Shimadzu Medical Systems	1991-11-01	35	0
K911563	INVENTOR RT/EXPLORER TRAUMA UNIT	Continental X-Ray Corp.	1991-10-23	198	0
K912696	TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL	Bennett X-Ray Corp.	1991-09-16	90	0
K900234	PFM-90 CEILING TUBE SUPPORT	Fischer Imaging Corp.	1990-02-26	40	0
K895188	SHIMADZU X-RAY TUBE STAND FH-31	Shimadzu Medical Systems	1989-09-22	42	0
K893653	RADIOGRAPHIC CEILING TUBE SUPPORT CTS15	Fischer Imaging Corp.	1989-06-23	39	0
K893652	RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60	Fischer Imaging Corp.	1989-06-23	39	0
K883664	LUM VASCULAR PROCEDURE SYSTEM #B5200A	General Electric Co.	1988-11-07	73	0
K883864	RADKOR SFR-70	Radkor, Inc.	1988-10-19	36	0
K881701	RADKOR SFC-21	Radkor, Inc.	1988-09-08	142	0
K882563	RADKOR, CST-18	Radkor, Inc.	1988-07-08	17	0
K880530	CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX	Fischer Imaging Corp.	1988-03-03	23	2
K880528	OVERHEAD TUBE MOUNT CASCADE II	Fischer Imaging Corp.	1988-02-29	20	0
K873283	MODEL C2-5000 OVERHEAD TUBE SUPPORT	Transworld X-Ray Corp.	1987-09-10	24	0
K870856	COSMOS	Pausch Corp.	1987-03-30	27	0
K862734	CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND	D&R X-Ray Products, Inc.	1986-08-01	11	0
K862827	FCW TUBE STAND	Garrels X-Ray Products, Inc.	1986-08-01	7	0
K861995	MODEL RS-3 RADIOGRAPHIC STAND	Medicor USA , Ltd.	1986-06-19	27	0
K852952	TRAUMA STAND	Xre Corp.	1985-09-26	77	0
K853682	MOUNT TUBE RADIOGRAPHIC	X-Ray Systems	1985-09-19	15	0
K850198	FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG	Summit Industries, Inc.	1985-05-14	116	1
K844337	X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY	Quality X-Ray Manufacturing, Inc.	1985-02-21	105	0
K843928	COUNTERBALANCED VERTICAL CASSETTE HOLDER	Poersch Metal Mfg. Co.	1984-12-17	73	0
K843335	FLOOR MOUNTED X-RAY TUBESTAND	Medicor USA , Ltd.	1984-11-27	92	0
K811970	AP X-RAY TUBE ANGULATION DEVICE	Philips Medical Systems (Cleveland), Inc.	1981-08-13	34	0
K811195	ARGOSTAT	Tecnomed, Inc.	1981-06-09	40	0
K803162	X-RAY STAND & OPERATING CHAIR	Downs Surgical , Ltd.	1981-01-28	146	0
K781571	L/U ARM-VASCULAR	General Electric Co.	1978-11-27	74	0
K781065	PLURIMAT;RADIOGRAPHIC TUBE MOUNT	Tecnomed, Inc.	1978-07-17	21	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