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

DTR — Predicate Candidate Screening

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

85 daysmedian FDA review time

239 days90th percentile

91clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252541	Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W	Spectrum Medical S.R.L.	2026-03-12	212	0
K240908	Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Ca	Spectrum Medical , Ltd.	2025-07-08	462	0
K250150	VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood card	Sorin Group Italia S.R.L.	2025-05-30	129	0
K240190	MYOtherm XP Cardioplegia Delivery System with Cortiva BioAct	Medtronic	2024-02-23	30	0
K223879	Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S	Quara S.R.L.	2023-04-13	107	0
K220110	Quantum PureFlow Standard Heat Exchanger and Quantum PureFlo	Qura S.R.L	2022-05-06	113	0
K212688	Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow C	Qura S.R.L	2022-01-10	138	0
K201984	MPS 3 ND Myocardial Protection System	Quest Medical, Inc.	2020-11-20	126	0
K200438	MPS 3 Myocardial Protection System	Quest Medical, Inc.	2020-06-19	116	0
K173716	MPS2 Myocardial Protection System Console	Quest Medical, Inc.	2018-10-01	300	0
K162774	MYOtherm XP Cardioplegia Delivery System with Cortiva BioAct	Medtronic, Inc.	2017-02-10	130	0
K162958	MYOtherm XP Cardioplegia Delivery System with Trillium Biosu	Medtronic, Inc.	2017-02-01	100	0
K090555	PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, M	Maquet Cardiopulmonary, AG	2009-12-23	296	1
K081838	GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING	Gish Biomedical, Inc.	2009-01-26	210	0
K072583	PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING,	Maquet Cardiopulmonary, AG	2008-04-04	204	0
K041979	MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201	Quest Medical, Inc.	2004-09-02	41	1
K040355	VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCH	Gish Biomedical, Inc.	2004-03-15	32	1
K032068	CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200	Cardiovention, Inc.	2003-08-22	50	0
K021830	SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOP	Cobe Cardiovascular, Inc.	2002-07-02	28	0
K020106	VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXC	Gish Biomedical, Inc.	2002-04-10	89	0
K012898	MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM	Cobe Cardiovascular, Inc.	2001-09-17	19	0
K000977	COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER	Olson Medical Sales, Inc.	2001-03-23	361	1
K003724	CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOA	Medtronic Vascular	2000-12-21	17	0
K991137	ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER	Minntech Corp.	2000-06-08	430	0
K982467	CAPIOX CARDIOPLEGIA	Terumo Medical Corp.	1999-06-23	343	0
K973475	CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTX	Medtronic Vascular	1997-11-20	69	0
K964571	VISION CARDIOPLEGIA DELIVERY SYSTEM	Lifestream Int'L, Inc.	1997-08-08	267	0
K962320	S3 CARDIOPLEGIA CONTROL	Stoeckert Instrumente	1997-01-10	207	0
K953838	MYOCARDIAL PROTECTION SYSTEM	Quest Medical, Inc.	1996-03-06	203	3
K944219	SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS	Gish Biomedical, Inc.	1995-06-30	305	0
K944267	HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA	Cobe Cardiovascular, Inc.	1995-04-28	239	0
K934355	ELECTROMEDICS BLOOD HEAT EXCHANGER	Electromedics, Inc.	1993-12-03	87	0
K932251	ROTATOR;MALE-MALE, MALE-FEMALE	Merit Medical Systems, Inc.	1993-08-05	87	0
K931967	HE-30 GOLD	Bentley Laboratories, Inc.	1993-07-13	83	0
K925369	BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS	Sorin Biomedica, Fiat, USA, Inc.	1993-03-26	154	0
K923311	CONDUCER HEAT EXCHANGER	3M Health Care, Sarns	1992-09-18	73	0
K913077	LANCASTER COOLING JACKET, CAT. CODE #13500/13501	Dlp, Inc.	1992-01-09	182	0
K913691	CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES	Gish Biomedical, Inc.	1991-12-18	121	0
K914742	MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF	Medtronic Vascular	1991-12-04	84	0
K905500	MYOCARDIAL PROTECTION SYSTEM	Medtronic Vascular	1991-06-10	185	0
K910923	BCD ADVANCED	Shiley, Inc.	1991-04-09	35	0
K905568	TOPICAL COOLING PAD, MODEL 7000	Daily Medical Products, Inc.	1991-01-23	42	0
K904171	SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM	Scimed	1990-12-06	86	0
K896807	SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM	Gish Biomedical, Inc.	1990-07-31	239	0
K896020	EXTRACORPOREAL HEAT EXCHANGER HE SERIES	Gish Biomedical, Inc.	1990-05-17	213	0
K900640	MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU	3M Company	1990-04-20	70	4
K897039	SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)	3M Company	1990-03-16	88	1
K884560	SCIMED ECMOTHERM(TM) HEAT EXCHANGER	Scimed Life Systems, Inc.	1989-04-03	154	0
K883071	SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM	3M Health Care, Sarns	1988-12-05	138	0
K883439	INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM	Medtronic Blood Systems, Inc.	1988-10-13	59	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