Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Cardinal Health, Inc. · Predicate Candidate Screening

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

103 daysmedian FDA review time

177 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170198	Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgi	Cardinal Health, Inc.	2017-06-15	143	0
K160411	Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera	Cardinal Health, Inc.	2016-07-25	160	0
K160875	Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic	Cardinal Health, Inc.	2016-07-11	103	0
K153316	Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves	Cardinal Health, Inc.	2016-05-12	177	0
K122696	POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)	Cardinal Health, Inc.	2013-01-31	149	0
K121897	PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES	Cardinal Health, Inc.	2012-07-27	28	0
K120934	PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOV	Cardinal Health, Inc.	2012-05-23	56	0
K111878	PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOV	Cardinal Health, Inc.	2011-09-29	90	0
K110272	STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR	Cardinal Health, Inc.	2011-06-08	128	0
K111015	STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COAT	Cardinal Health, Inc.	2011-05-06	25	0
K110921	NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH C	Cardinal Health, Inc.	2011-04-15	14	0
K103249	NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH	Cardinal Health, Inc.	2010-12-16	43	0
K102500	STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE CO	Cardinal Health, Inc.	2010-11-04	64	0
K101811	PROTEGRITY SMT LATEX SURGICALGLOVES	Cardinal Health, Inc.	2010-10-15	108	0
K092684	LAPAROSCOPIC RETRACTORS	Cardinal Health, Inc.	2010-01-22	143	1
K090915	STERILE WATER FOR INHALATION FLEX BAG, USP	Cardinal Health, Inc.	2009-11-18	231	0
K093300	ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES	Cardinal Health, Inc.	2009-10-30	9	0
K092304	ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES	Cardinal Health, Inc.	2009-09-15	48	0
K090211	INFLATABLE BONE TAMP	Cardinal Health, Inc.	2009-07-01	154	0
K091250	DIAGNOSTIC CATHETER SYSTEM	Cardinal Health, Inc.	2009-05-22	24	0
K090272	SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)	Cardinal Health, Inc.	2009-03-18	42	0
K072964	NICOLET CORTICAL STIMULATOR	Cardinal Health, Inc.	2008-12-30	438	3
K072133	AVAFLEX VERTEBRAL AUGMENTATION NEEDLE	Cardinal Health, Inc.	2007-11-20	110	0
K070647	TRIFLEX SELECT	Cardinal Health, Inc.	2007-06-22	106	0
K070091	COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213	Cardinal Health, Inc.	2007-04-18	98	0
K061762	TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N	Cardinal Health, Inc.	2006-08-01	40	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