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

Akcess Medical Products, Inc. · Predicate Candidate Screening

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

78 daysmedian FDA review time

504 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K926374	SILICONE CATHETER REPAIR KITS	Akcess Medical Products, Inc.	1994-10-07	654
K925819	AKCESS0CATH KIT	Akcess Medical Products, Inc.	1994-08-02	623
K925818	AKCESS-CATH	Akcess Medical Products, Inc.	1994-04-05	504
K930630	RIGHT ATRIAL CATHETER	Akcess Medical Products, Inc.	1994-02-07	364
K920634	SPLITTABLE SHEATH INTRODUCER SET	Akcess Medical Products, Inc.	1994-01-14	702
K931120	COAXIAL ACUTE CATHETER	Akcess Medical Products, Inc.	1994-01-14	316
K914936	CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET	Akcess Medical Products, Inc.	1992-04-23	171
K920331	RIGHT ATRIAL CATHETER KITS	Akcess Medical Products, Inc.	1992-04-22	90
K914826	AKCESS-CATH KIT	Akcess Medical Products, Inc.	1992-04-10	168
K915215	CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS	Akcess Medical Products, Inc.	1992-03-27	130
K911333	RIGHT ATRIAL CATHETERS	Akcess Medical Products, Inc.	1991-09-23	181
K910501	PERMANENT SILICONE CATHETERS	Akcess Medical Products, Inc.	1991-04-29	83
K910502	VESSEL DILATORS	Akcess Medical Products, Inc.	1991-04-29	83
K910572	INJECTION CAPS	Akcess Medical Products, Inc.	1991-04-29	77
K910641	INTRODUCER NEEDLES	Akcess Medical Products, Inc.	1991-04-29	75
K910321	Y ADAPTOR	Akcess Medical Products, Inc.	1991-04-16	82
K904139	SINGLE LUMEN CATHETER KITS	Akcess Medical Products, Inc.	1990-12-04	89
K904140	SINGLE LUMEN CATHETERS, MODIFICATION	Akcess Medical Products, Inc.	1990-11-27	82
K904433	DUAL LUMEN NEEDLES	Akcess Medical Products, Inc.	1990-11-23	56
K902203	TENCKHOFF PERITONEAL DIALYSIS KIT	Akcess Medical Products, Inc.	1990-08-01	77
K902101	PERITONEAL CATHETERS	Akcess Medical Products, Inc.	1990-07-27	80
K901061	SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000	Akcess Medical Products, Inc.	1990-05-22	78
K900803	DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S	Akcess Medical Products, Inc.	1990-04-25	64
K893679	SHUNT CONNECTORS	Akcess Medical Products, Inc.	1989-07-24	69
K891753	DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800	Akcess Medical Products, Inc.	1989-06-08	77
K891755	DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K	Akcess Medical Products, Inc.	1989-06-08	77
K893438	T SERIES VESSEL TIPS	Akcess Medical Products, Inc.	1989-06-08	36
K893478	DA-16 AND DA-24 SHUNT ADAPTERS	Akcess Medical Products, Inc.	1989-06-08	35
K892887	ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA	Akcess Medical Products, Inc.	1989-05-15	25
K892663	S-100 ALLEN-BROWN SHUNT	Akcess Medical Products, Inc.	1989-05-04	21
K892666	SAF-T-SHUNT, S-300 SERIES	Akcess Medical Products, Inc.	1989-05-04	21
K892667	SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313	Akcess Medical Products, Inc.	1989-05-04	21
K891752	DA-46 FLUID BARRIER	Akcess Medical Products, Inc.	1989-04-07	15
K891754	DC-4 SHUNT INFUSION T	Akcess Medical Products, Inc.	1989-04-07	15
K891763	FC-100 FEMORAL CATHETER	Akcess Medical Products, Inc.	1989-04-07	14
K891764	FC-101 FEMORAL CATHETER GUIDE WIRE	Akcess Medical Products, Inc.	1989-04-07	14

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