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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2013 | K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Dec 18, 2012 | K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc. | DWC |
| Jul 3, 2012 | K121669 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) Cincinnati Sub-Zero Products, Inc. | DWJ |
| Feb 17, 2012 | K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Feb 4, 2011 | K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM Cincinnati Sub-Zero Products, Inc. | DWJ |
| Oct 1, 2010 | K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Sep 20, 2010 | K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Dec 13, 2007 | K072621 | ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR Cincinnati Sub-Zero Products, Inc. | BZT |
| Sep 26, 2007 | K070339 | DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES Cincinnati Sub-Zero Products, Inc. | FLL |
| Jan 24, 1995 | K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) Cincinnati Sub-Zero Products, Inc. | DWJ |
| Jan 24, 1995 | K942599 | WARM AIR WARMING UNIT Cincinnati Sub-Zero Products, Inc. | DWJ |
| May 16, 1991 | K910327 | WARMAIR SYSTEM Cincinnati Sub-Zero Products, Inc. | DWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2018 | Cincinnati 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 |
DWC | K122813 |
| Mar 9, 2017 | Cincinnati Sub-Zero Products Inc Hemotherm CE, model 400CE, Heater-Cooling Device Terminated |
DWC | K122813 |
| Nov 22, 2016 | Cincinnati Sub-Zero Products Inc The Hemotherm 400CE 115v, containing power board p/n 39945 Terminated |
DWS | K122813 |
| Feb 19, 2015 | Cincinnati 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 |
ILO | K843146 K902269 |
| Jun 10, 2014 | Cincinnati 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 |
DWJ | K110104 |
| Dec 4, 2013 | Cincinnati 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 |
DWJ | None listed |
| Sep 16, 2013 | Cincinnati 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 |
DWJ | K101589 |
| May 24, 2012 | Cincinnati 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 |
DWJ | None listed |
| Feb 7, 2012 | Cincinnati 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 |
DWJ | None listed |
| Feb 7, 2012 | Cincinnati 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 |
DWJ | None listed |
| Jan 11, 2012 | Cincinnati 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 |
BZT | K072621 |
| Sep 1, 2011 | Cincinnati 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 |
DWJ | K101148 |
| Jul 27, 2011 | Cincinnati 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 |
DWJ | K101148 |
| Jul 14, 2011 | Cincinnati 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 |
DWJ | None listed |
| Jul 1, 2011 | Cincinnati 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 |
DWJ | K811742 |
| Jul 1, 2011 | Cincinnati 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 |
DWJ | K811742 |
| Mar 30, 2011 | Cincinnati 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 |
DWJ | K101589 |
| Feb 4, 2010 | Cincinnati 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 |
ILO | None listed |
| Feb 4, 2010 | Cincinnati Sub-Zero Products Inc FilteredFlo Cardiac Blanket.
The device is used to distribute heated air around a patient (for patient warming). Terminated |
DWJ | K942599 |
| Oct 29, 2009 | Cincinnati 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 |
DWJ | K942599 |
| Apr 6, 2005 | Cincinnati Sub-Zero Products Inc Micro-temp II heat therapy unit, model #747. Terminated |
ILO | K843146 |
| Apr 6, 2005 | Cincinnati Sub-Zero Products Inc Electri-Cool II Terminated |
ILO | None listed |
| Dec 30, 2004 | Cincinnati Sub-Zero Products Warm Air Model 135 Warming Units. Terminated |
BTE | K942599 |