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

Medicor USA , Ltd. — Predicate Candidate Screening

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

64 daysmedian FDA review time

124 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K861994	MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM	Medicor USA , Ltd.	1986-07-18	56
K861995	MODEL RS-3 RADIOGRAPHIC STAND	Medicor USA , Ltd.	1986-06-19	27
K860025	MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR	Medicor USA , Ltd.	1986-05-07	124
K850761	MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C	Medicor USA , Ltd.	1985-09-19	206
K851358	MODEL BION 2/TYPE 90 ROOM IONIZER	Medicor USA , Ltd.	1985-07-01	88
K851094	MODEL BION 1/TYPE 1084T CAR IONIZER	Medicor USA , Ltd.	1985-06-19	92
K843335	FLOOR MOUNTED X-RAY TUBESTAND	Medicor USA , Ltd.	1984-11-27	92
K840227	UROLIX-3 UROLOGICAL TABLE	Medicor USA , Ltd.	1984-03-23	64
K840225	C-ARM CEILING CRANE FT-2	Medicor USA , Ltd.	1984-03-22	63
K840226	MOTOR TILTED EXAM. TABLE UV-56	Medicor USA , Ltd.	1984-03-16	57
K823695	CPM METABOLIC MONITOR	Medicor USA , Ltd.	1983-01-14	37
K791287	MEDICOR QUALITY CONTROL BUFFER	Medicor USA , Ltd.	1979-08-16	37
K790803	SYRINGE TONOMETER	Medicor USA , Ltd.	1979-06-28	64
K781417	PRECISION GAS MIXER	Medicor USA , Ltd.	1978-09-20	35

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