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

ITY — Predicate Candidate Screening

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

67 daysmedian FDA review time

206 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K000052	X-RAY MONOBLOCK, MONOBLOCK XRS-60-330	Dynarad Corp.	2000-02-10	34
K933162	MRX-750	Mrx Corp.	1993-10-07	100
K923094	MOLYBDENUM	Southeastern Medical Diagnostics, Inc.	1993-03-04	252
K923141	PHILIPS PRE-FILTER OPTION	Philips Medical Systems, Inc.	1993-01-21	206
K921129	MRX-700	Mrx-Ray Tube Corp.	1992-10-05	209
K921130	MRX-865	Mrx-Ray Tube Corp.	1992-09-10	184
K921316	MG-1001 TUBE HOUSING ASSEMBLY	Magma Corp.	1992-06-22	97
K920731	X-RAY TUBE ASSEMBLY CIRCLEX1.2UG	Shimadzu Medical Systems	1992-05-29	101
K920724	HIGH SPEED ROTATION STARTER SA-50	Shimadzu Medical Systems	1992-04-27	69
K920723	HIGH SPEED ROTATION STARTER SA-40	Shimadzu Medical Systems	1992-04-27	69
K920387	CIRCLEXO.3T X-RAY TUBE ASSEMBLY	Shimadzu Medical Systems	1992-04-14	75
K913987	OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID	Codman & Shurtleff, Inc.	1992-04-13	221
K913301	MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM	Comet North America, Inc.	1991-08-28	34
K912338	TUBE HOUSING ASSEMBLIES	Comet Ltd. C/O Radiology Resources, Inc.	1991-08-07	75
K911695	VARIOUS X-RAY TUBES	Comet Ltd. C/O Radiology Resources, Inc.	1991-06-19	64
K910308	X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110	Inmark Corp.	1991-03-27	62
K910276	X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51	Inmark Corp.	1991-03-06	42
K910842	DI2000/HS-45-150 X-RAY TUBE INSERT	Comet Ltd. C/O Radiology Resources, Inc.	1991-03-06	7
K904182	R-800-SF	Advantech	1990-11-13	63
K900367	HOFMANN-NAGEL (HOFNA) X-RAY TUBES	Hofmann	1990-02-26	31
K894742	RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS	Inmark Corp.	1989-10-27	102
K894413	X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS	Inmark Corp.	1989-09-22	67
K882939	NIOBI-X RADIATION REDUCTION FILTER	American Canadian Products, Inc.	1988-11-04	114
K882323	MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000	Meicor, Inc.	1988-06-30	24
K873314	TOSHIBA, SMIT ROENTGEN	Inland Tube Corp.	1987-11-02	75
K871227	LES RAD FILTER	M. D. Products	1987-06-29	94
K870071	TOSHIBA, SMIT ROENTGEN	North American Imaging, Inc.	1987-01-21	13
K864042	MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH	Absolute X-Ray Corp.	1986-10-27	11
K860760	ERBIUM X-RAY FILTER	Reactor Experiments, Inc.	1986-06-10	102
K860504	36-101 XDS111 XENON DELIVERY/TRAP SYSTEM	Victoreen, Inc.	1986-04-04	52
K840135	CRISA	X-Ray Tube Corp.	1984-03-23	80
K834306	PHASIX-HIGH FREQUENCY GENERATOR	Cgr Medical Corp.	1983-12-29	55
K833847	CRISA	X-Ray Tube Corp.	1983-12-12	88
K833238	CRISA	X-Ray Tube Corp.	1983-10-28	49
K812915	MX 125	General Electric Co.	1981-11-24	36
K810190	OPTI 110/12/50HSG	Siemens Corp.	1981-03-02	38
K781524	MAXIRAY 125 TUBE UNIT	General Electric Co.	1978-10-17	42
K781540	OPTI 110/12/50 HSG	Siemens Corp.	1978-09-14	6
K770336	X-RAY TUBE, ROTATING ANODE	Litton Medical Systems	1977-03-01	11
K760604	EUREKA X-SCAN 150 X-RAY TUBE HOUSING AS.	Eureka X-Ray Tube Corp.	1976-09-13	5

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