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

DWB — Predicate Candidate Screening

21 FDA 510(k) clearances under this product code; the 50 most recent screened below.

110 daysmedian FDA review time

245 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162843	Small (4) Roller Pump for the Terumo Advanced Perfusion Syst	Terumo Cardiovascular Systems Corporation	2016-11-17	37	0
K131618	LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1	Terumo Cardiovascular Systems Corporation	2013-09-27	116	0
K112587	ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLL	Terumo Cardiovascular Systems Corp.	2011-12-19	104	0
K973237	CSS-CARDIOPLEGIA SAFETY SYSTEM	Medtronic Bio-Medicus, Inc.	1998-04-27	242	0
K972321	S3 MAST PUMP	Stoeckert Instrumente	1998-02-27	249	0
K971520	S3 CYCLIC RPM CONTROL	Stoeckert Instrumente	1997-09-10	138	0
K960974	COBE CENTURY PERFUSION PUMP	Cobe Cardiovascular, Inc.	1997-07-14	490	0
K953904	SARNS 9000 UNIVERSAL ROLLER PUMP	3M Health Care, Ltd.	1996-04-19	245	3
K953901	SARNS 800 ROLLER PUMP	3M Health Care, Sarns	1996-04-19	245	0
K955038	STOCKERT S3 DOUBLE HEAD PUMP MODULE	Stoeckert Instrumente	1996-02-21	110	0
K890904	MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP	Shiley, Inc.	1989-04-12	61	0
K881780	VASCUCARE ANGIOPUMP	Vascucare, Inc.	1988-09-28	155	0
K874771	ANGIOMED INTRODUCING SETS	Angiomed U.S., Inc.	1988-01-12	54	0
K861714	STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE	Shiley, Inc.	1986-07-16	72	0
K862116	STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE	Shiley, Inc.	1986-07-16	43	0
K831458	CARDIOPLEGIA RECIRCULATION SYS-BL 705/A	Electromedics, Inc.	1983-10-20	167	0
K820729	SARNS PULSATILE PUMP	3M Health Care, Sarns	1982-11-01	229	0
K822071	PUMP MODULES PMO LO-110-PMD 10-210	Gambro, Inc.	1982-08-24	41	0
K813035	POLYSTAN VERTICLUDE BLOOD PUMP	Advocacy International, Ltd.	1981-11-27	30	0
K802714	COBE/STOCKERT BATTERY MODULE	Cobe Laboratories, Inc.	1980-11-26	26	0
K780942	BLOOD PUMP MODEL 7000	3M Health Care, Sarns	1978-06-19	12	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