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

E-Z-Em, Inc. · Predicate Candidate Screening

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

86 daysmedian FDA review time
234 days90th percentile
56clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/E-Z-Em, Inc.2007-06-13270
K062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730E-Z-Em, Inc.2007-04-132340
K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900E-Z-Em, Inc.2006-11-02310
K053008E-Z-EM ENDOSCOPIC CO2 REGULATORE-Z-Em, Inc.2005-12-27620
K041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.2004-07-16720
K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825E-Z-Em, Inc.2003-06-19303
K030854PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, ME-Z-Em, Inc.2003-04-16290
K013219PROTOCO2L INSUFFLATOR MODEL 6400E-Z-Em, Inc.2002-02-191460
K011160E-Z EM PERCUPUMP 2001 CT INJECTORE-Z-Em, Inc.2001-05-16303
K974621PERCUPUMP II WITH EDAE-Z-Em, Inc.1998-01-27470
K961845PERCUPUMP II WITH EDAE-Z-Em, Inc.1997-01-232550
K954926HM-CAP CONTROL PANELE-Z-Em, Inc.1996-01-30960
K932055PERCUPUMP IIE-Z-Em, Inc.1995-03-216920
K930581E-Z-FLATEE-Z-Em, Inc.1994-07-015120
K911349E-Z-EM ENTEROCLYSIS CATHETER SETE-Z-Em, Inc.1992-11-166000
K914984E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATIONE-Z-Em, Inc.1992-05-202100
K914987HIGH PRESSURE CONNECTING SETS, MODIFICATIONE-Z-Em, Inc.1992-05-202090
K914986GUIDE WIRES, MODIFICATIONE-Z-Em, Inc.1992-05-202090
K921738SONO-VU US(TM), MODIFICATIONE-Z-Em, Inc.1992-04-27890
K920816PERCUGUIDE LESION MARKINGE-Z-Em, Inc.1992-04-21750
K914113ANGIOGRAPHIC FLUSH SYSTEME-Z-Em, Inc.1992-01-221310
K914026ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEME-Z-Em, Inc.1992-01-091210
K914985DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATIONE-Z-Em, Inc.1991-12-20580
K914330SOS BLOODLESS NEEDLEE-Z-Em, Inc.1991-12-20840
K914199ANGIOGRAPHIC SOFT TIP CATHETERE-Z-Em, Inc.1991-12-18900
K911897GASPARAITIS ESOPHAGRAM CATHETER SETE-Z-Em, Inc.1991-07-24860
K904583SONO-VU US(TM)E-Z-Em, Inc.1991-06-242580
K905409EIA FOR DETECTION OF ANTIBODIES H. PYLORIE-Z-Em, Inc.1991-06-101890
K905447E-Z-EM PULSED INFUSION SYSTEME-Z-Em, Inc.1991-04-011174
K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.1991-01-24430
K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.1990-11-27690
K900021PERCU-SET(TM)E-Z-Em, Inc.1990-03-29860
K895012E-Z-EM VACUUM ASPIRATION SYRINGEE-Z-Em, Inc.1989-12-271410
K890207INTERVENTIONAL PRODUCTS - GUIDE WIRESE-Z-Em, Inc.1989-05-311340
K890208HIGH PRESSURE CONNECTING SETSE-Z-Em, Inc.1989-05-191220
K890206E-Z-FLOW ANGIOGRAPHY CATHETERSE-Z-Em, Inc.1989-05-191220
K890209DISPOSABLE ANGIOGRAPHY NEEDLESE-Z-Em, Inc.1989-05-191220
K885264WINGED INFUSION SETE-Z-Em, Inc.1989-01-31400
K882601E-Z-EM(R) LUFKIN BIOPSY NEEDLESE-Z-Em, Inc.1988-07-25310
K864227PERCUPUMP (TM)E-Z-Em, Inc.1987-01-16800
K863090PERCU GUIDE I (LOOP TYPE)E-Z-Em, Inc.1986-08-29160
K853667BRONCHIAL CYTOLOGY BRUSHE-Z-Em, Inc.1985-12-181060
K854248GOODLEY POLYAXIAL CERVICAL TRACTION UNITE-Z-Em, Inc.1985-11-15250
K853384E-Z-EM GASTRIC LAVAGE CATHETERE-Z-Em, Inc.1985-11-05850
K853666ENDODYNAMICS SIEGEL THERAPUTIC STENTE-Z-Em, Inc.1985-11-05630
K853680ENDODYNAMIC SIEGEL SPHINCTEROTOMEE-Z-Em, Inc.1985-11-04610
K853402E-Z-GUARD MOUTHPIECEE-Z-Em, Inc.1985-10-23720
K853530ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSHE-Z-Em, Inc.1985-10-04420
K842121E-Z-EM SINGLE STICK PUNCTURE/DRAINAGEE-Z-Em, Inc.1984-10-011250
K841720E-Z-EM PERCUTANEOUS NEPHROSTOMY SETSE-Z-Em, Inc.1984-07-26920

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