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

DWC — Predicate Candidate Screening

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

88 daysmedian FDA review time

257 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220635	Heater-Cooler System 3T	Livanova Deutschland, GmbH	2022-11-16	257	0
K212657	Quantum Heater-Cooler	Spectrum Medical , Ltd.	2022-05-06	256	0
K191402	Heater-Cooler System 3T	Livanova Deutschland, GmbH	2020-02-25	277	1
K140012	SORIN FLEXTHERM	Sorin Group Deutschland GmbH	2014-01-31	29	0
K130300	HEATER-COOLER UNIT HCU 40	Maquet Cardiopulmonary, AG	2013-07-01	144	0
K122813	HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM	Cincinnati Sub-Zero Products, Inc.	2012-12-18	96	3
K102147	CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000	Cardioquip Llp	2010-11-19	112	8
K071521	TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM	Terumo Cardiovascular Systems Corp.	2007-11-21	170	5
K052601	STOCKERT HEATER-COOLER SYSTEM 3T	Sorin Group Deutschland GmbH	2006-06-06	258	15
K031544	HEATER COOLER UNIT, MODEL HCU 30	Jostra AB	2003-08-07	83	2
K014016	ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER	Minntech Corp.	2002-02-01	58	0
K003145	ORIGEN BLADDER HOLDER	Origen Biomedical, Inc.	2001-04-20	192	0
K001520	ALPHA OMEGA DUAL COOLER-HEATER	Alpha Omega, Inc.	2000-11-22	190	0
K945720	JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED	Jostra Bentley	1995-03-29	128	0
K896972	CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520	Daily Medical Products, Inc.	1990-02-05	54	0
K896971	CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420	Daily Medical Products, Inc.	1990-02-05	54	0
K896973	CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320	Daily Medical Products, Inc.	1990-02-05	54	0
K896974	CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120	Daily Medical Products, Inc.	1990-02-05	54	0
K896975	CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220	Daily Medical Products, Inc.	1990-02-05	54	0
K896393	CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620	Daily Medical, Inc.	1990-02-02	88	0
K893940	POLYSTAN HEATER-COOLER UNIT	Polystan C/O Vitalcor, Inc.	1990-01-18	232	0
K883603	SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)	3M Health Care, Sarns	1988-11-03	72	3
K873924	PTI HEART-CHILL POUCH/PAD SLING (STERILE)	Buckman Co., Inc.	1988-02-02	130	0
K874927	PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET	Pioneering Technologies, Inc.	1988-01-29	58	0
K873699	ECMO-TEMP (TM) BLOOD WARMING DEVICE	Seabrook Medical Systems, Inc.	1987-12-22	97	0
K873813	SARNS WARMER, PART #164975 AND #164980	3M Health Care, Sarns	1987-11-06	49	0
K841402	TEMPERATURE CONTROL & MONITOR	Sams, Inc.	1984-06-11	69	2
K831677	HYPER-HYPOTHERMIA UNIT HYPO 10-200	Gambro, Inc.	1983-07-18	56	0
K822874	THERMOSTATIC WATER MIXING VALVE TWV10	Gambro, Inc.	1982-10-18	21	0
K810647	SHILEY OXYGENATOR THERMISTOR PROBE	Shiley, Inc.	1981-04-03	23	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