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

Medrad, Inc. — Predicate Candidate Screening

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

75 daysmedian FDA review time

214 days90th percentile

105clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K133023	JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.8	Medrad, Inc.	2014-08-27	335	1
K130381	ANGIOJET ULTRA POWER PULSE KIT	Medrad, Inc.	2013-07-29	165	0
K130637	JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JE	Medrad, Inc.	2013-04-10	30	0
K122916	JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREA	Medrad, Inc.	2012-10-19	28	0
K113363	ANGIOJET SOLENT DISTA THROMBECTOMY SET	Medrad, Inc.	2012-06-06	204	1
K113133	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTE	Medrad, Inc.	2011-12-15	52	0
K113428	ANGIOJET ULTRA DVX THROMBECTOMY SET	Medrad, Inc.	2011-12-02	11	0
K112086	MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM	Medrad, Inc.	2011-10-14	85	0
K111182	ANGIOJET SOLENT OMNI THROMBECTOMY SET	Medrad, Inc.	2011-05-24	27	1
K100798	MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET	Medrad, Inc.	2010-06-23	93	3
K082905	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC	Medrad, Inc.	2009-01-12	104	1
K082458	P3T ABDOMEN	Medrad, Inc.	2008-10-17	52	0
K080297	MEDRAD INTEGO PET INFUSION SYSTEM	Medrad, Inc.	2008-06-17	134	1
K073051	MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACC	Medrad, Inc.	2008-05-30	214	2
K072886	MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T	Medrad, Inc.	2007-12-21	73	0
K063090	MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY	Medrad, Inc.	2007-03-27	168	0
K063342	MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS	Medrad, Inc.	2006-11-30	24	0
K061128	MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM	Medrad, Inc.	2006-05-22	28	0
K060401	MEDRAD 3.0T ECOIL IMAGING SYSTEM	Medrad, Inc.	2006-03-15	28	0
K053042	MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE	Medrad, Inc.	2005-11-17	20	0
K052827	MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR	Medrad, Inc.	2005-11-01	27	0
K051349	3.0T PROSTATE IMAGING SYSTEM	Medrad, Inc.	2005-06-23	30	0
K050456	MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM	Medrad, Inc.	2005-06-17	114	6
K050371	MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER	Medrad, Inc.	2005-06-07	113	0
K042784	MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM	Medrad, Inc.	2004-12-10	65	0
K033881	MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTER	Medrad, Inc.	2004-03-02	78	1
K033247	MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM	Medrad, Inc.	2003-11-05	29	0
K032771	MEDRAD CONTINUUM MR INFUSION SYSTEM	Medrad, Inc.	2003-09-23	15	1
K031483	MEDRAD MANUAL SYRINGE LOADER	Medrad, Inc.	2003-08-01	81	0
K031808	MEDRAD SWABBABLE VALVE TRANSFER SET	Medrad, Inc.	2003-07-11	29	0
K023183	MEDRAD STELLANT CT INJECTOR SYSTEM	Medrad, Inc.	2003-01-10	108	5
K023596	MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL	Medrad, Inc.	2002-11-08	11	0
K022431	MEDRAD TRANSFER SET	Medrad, Inc.	2002-09-05	42	0
K021988	MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM	Medrad, Inc.	2002-08-29	72	1
K013815	MEDRAD QWIK-FIT SYRINGE	Medrad, Inc.	2001-12-13	27	0
K012950	MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM	Medrad, Inc.	2001-10-04	30	0
K011991	MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR	Medrad, Inc.	2001-08-21	56	0
K001663	FRONT-LOAD POLYPROPYLENE SYRINGE	Medrad, Inc.	2000-11-16	169	0
K993728	MEDRAD ENVISION CT INJECTOR SYSTEM	Medrad, Inc.	1999-11-26	22	0
K991557	MEDRAD VISTRON CT INJECTOR SYSTEM	Medrad, Inc.	1999-07-21	78	0
K984418	UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET	Medrad, Inc.	1999-03-11	91	0
K984257	MEDRAD PHASED ARRAY NEUROVASCULAR COIL	Medrad, Inc.	1999-01-25	56	0
K984159	MEDRAD QUADRATURE CTL ARRAY COIL	Medrad, Inc.	1999-01-12	54	0
K982921	MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA,	Medrad, Inc.	1998-11-03	76	0
K982959	MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42	Medrad, Inc.	1998-11-03	71	0
K982919	MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42T	Medrad, Inc.	1998-11-02	75	0
K982932	MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC	Medrad, Inc.	1998-11-02	74	0
K982916	MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SH	Medrad, Inc.	1998-10-29	71	0
K982814	MEDRAD VISTRON CT INJECTOR SYSTEM	Medrad, Inc.	1998-10-09	59	0
K981094	MEDRAD NEUROVASCULAR COIL	Medrad, Inc.	1998-06-18	84	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