Atlas FDA

DWC

30 FDA 510(k) clearances · Product code

88 daysmedian time to decision
257 days90th percentile
30clearances measured

FDA profile

Official device name
Controller, Temperature, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4250
Medical specialty
Cardiovascular
Flags
Life-sustaining
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Adverse events (MAUDE)
2021: 622 · 2022: 605 · 2023: 928 · 2024: 555 · 2025: 680 · 2026: 343
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Heater-Cooler System 3T (K220635)Livanova Deutschland, GmbH2022-11-16
Quantum Heater-Cooler (K212657)Spectrum Medical , Ltd.2022-05-06
Heater-Cooler System 3T (K191402)Livanova Deutschland, GmbH2020-02-25
SORIN FLEXTHERM (K140012)Sorin Group Deutschland GmbH2014-01-31
HEATER-COOLER UNIT HCU 40 (K130300)Maquet Cardiopulmonary, AG2013-07-01
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813)Cincinnati Sub-Zero Products, Inc.2012-12-18
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147)Cardioquip Llp2010-11-19
TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521)Terumo Cardiovascular Systems Corp.2007-11-21
STOCKERT HEATER-COOLER SYSTEM 3T (K052601)Sorin Group Deutschland GmbH2006-06-06
HEATER COOLER UNIT, MODEL HCU 30 (K031544)Jostra AB2003-08-07
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016)Minntech Corp.2002-02-01
ORIGEN BLADDER HOLDER (K003145)Origen Biomedical, Inc.2001-04-20
ALPHA OMEGA DUAL COOLER-HEATER (K001520)Alpha Omega, Inc.2000-11-22
JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICE (K945720)Jostra Bentley1995-03-29
CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520 (K896972)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420 (K896971)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320 (K896973)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120 (K896974)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220 (K896975)Daily Medical Products, Inc.1990-02-05
CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620 (K896393)Daily Medical, Inc.1990-02-02
POLYSTAN HEATER-COOLER UNIT (K893940)Polystan C/O Vitalcor, Inc.1990-01-18
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II) (K883603)3M Health Care, Sarns1988-11-03
PTI HEART-CHILL POUCH/PAD SLING (STERILE) (K873924)Buckman Co., Inc.1988-02-02
PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET (K874927)Pioneering Technologies, Inc.1988-01-29
ECMO-TEMP (TM) BLOOD WARMING DEVICE (K873699)Seabrook Medical Systems, Inc.1987-12-22
SARNS WARMER, PART #164975 AND #164980 (K873813)3M Health Care, Sarns1987-11-06
TEMPERATURE CONTROL & MONITOR (K841402)Sams, Inc.1984-06-11
HYPER-HYPOTHERMIA UNIT HYPO 10-200 (K831677)Gambro, Inc.1983-07-18
THERMOSTATIC WATER MIXING VALVE TWV10 (K822874)Gambro, Inc.1982-10-18
SHILEY OXYGENATOR THERMISTOR PROBE (K810647)Shiley, Inc.1981-04-03

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