ClearanceBrief
Company ยท US

Cincinnati Sub-Zero Products Inc

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2013. Name variants (Inc, Corp, punctuation) are merged.

12510(k) clearances (0 in 12 months)
23recalls (0 in 12 months)
16recalls that name a 510(k)

Product codes

CodeDeviceRecords
DWJSystem, Thermal Regulating23
ILOPack, Hot Or Cold, Water Circulating4
DWCController, Temperature, Cardiopulmonary Bypass3
BZTStethoscope, Esophageal, With Electrical Conductors2
BTE1
DWSInstruments, Surgical, Cardiovascular1
FLLContinuous Measurement Thermometer1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 17, 2013K123946WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS
Cincinnati Sub-Zero Products, Inc.
DWJ
Dec 18, 2012K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
Cincinnati Sub-Zero Products, Inc.
DWC
Jul 3, 2012K121669WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Cincinnati Sub-Zero Products, Inc.
DWJ
Feb 17, 2012K120081NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
Cincinnati Sub-Zero Products, Inc.
DWJ
Feb 4, 2011K110104BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
Cincinnati Sub-Zero Products, Inc.
DWJ
Oct 1, 2010K101148WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
Cincinnati Sub-Zero Products, Inc.
DWJ
Sep 20, 2010K101589BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
Cincinnati Sub-Zero Products, Inc.
DWJ
Dec 13, 2007K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR
Cincinnati Sub-Zero Products, Inc.
BZT
Sep 26, 2007K070339DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
Cincinnati Sub-Zero Products, Inc.
FLL
Jan 24, 1995K942790WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133)
Cincinnati Sub-Zero Products, Inc.
DWJ
Jan 24, 1995K942599WARM AIR WARMING UNIT
Cincinnati Sub-Zero Products, Inc.
DWJ
May 16, 1991K910327WARMAIR SYSTEM
Cincinnati Sub-Zero Products, Inc.
DWJ

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 13, 2018Cincinnati Sub-Zero Products LLC
Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The de
Terminated
DWCK122813
Mar 9, 2017Cincinnati Sub-Zero Products Inc
Hemotherm CE, model 400CE, Heater-Cooling Device
Terminated
DWCK122813
Nov 22, 2016Cincinnati Sub-Zero Products Inc
The Hemotherm 400CE 115v, containing power board p/n 39945
Terminated
DWSK122813
Feb 19, 2015Cincinnati Sub-Zero Products Inc
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been position
Terminated
ILOK843146
K902269
Jun 10, 2014Cincinnati Sub-Zero Products Inc
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part numbe
Terminated
DWJK110104
Dec 4, 2013Cincinnati Sub-Zero Products Inc
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, w
Terminated
DWJNone listed
Sep 16, 2013Cincinnati Sub-Zero Products Inc
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maint
Terminated
DWJK101589
May 24, 2012Cincinnati Sub-Zero Products Inc
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonary by-pass temperature controllers. The ECMO Heaters are used in conjunction with a heat exchanger to warm the
Terminated
DWJNone listed
Feb 7, 2012Cincinnati Sub-Zero Products Inc
Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled w
Terminated
DWJNone listed
Feb 7, 2012Cincinnati Sub-Zero Products Inc
Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device,
Terminated
DWJNone listed
Jan 11, 2012Cincinnati Sub-Zero Products Inc
Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, Part Number: 39622, Catalog #491B. TA disposable temperature probe used in conjunction with a measuring/moni
Terminated
BZTK072621
Sep 1, 2011Cincinnati Sub-Zero Products Inc
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135
Terminated
DWJK101148
Jul 27, 2011Cincinnati Sub-Zero Products Inc
WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures through convec
Terminated
DWJK101148
Jul 14, 2011Cincinnati Sub-Zero Products Inc
Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, The WarmAir 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature.
Terminated
DWJNone listed
Jul 1, 2011Cincinnati Sub-Zero Products Inc
ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a pat
Terminated
DWJK811742
Jul 1, 2011Cincinnati Sub-Zero Products Inc
ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patie
Terminated
DWJK811742
Mar 30, 2011Cincinnati Sub-Zero Products Inc
115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. Used to lower or to raise a patient's temperatu
Terminated
DWJK101589
Feb 4, 2010Cincinnati Sub-Zero Products Inc
TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.
Terminated
ILONone listed
Feb 4, 2010Cincinnati Sub-Zero Products Inc
FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming).
Terminated
DWJK942599
Oct 29, 2009Cincinnati Sub-Zero Products Inc
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after su
Terminated
DWJK942599
Apr 6, 2005Cincinnati Sub-Zero Products Inc
Micro-temp II heat therapy unit, model #747.
Terminated
ILOK843146
Apr 6, 2005Cincinnati Sub-Zero Products Inc
Electri-Cool II
Terminated
ILONone listed
Dec 30, 2004Cincinnati Sub-Zero Products
Warm Air Model 135 Warming Units.
Terminated
BTEK942599
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