Data / Medical devices / United States / Gentherm Medical, LLC
Gentherm Medical, LLC: FDA-registered device maker in Cincinnati, OH, United States, 6 510(k) clearances
Gentherm Medical, LLC is registered with the FDA (registration 1516825) in Cincinnati, OH, United States. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 24, 2023. 28 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1516825
- Address
- 12011 Mosteller RD, Cincinnati, OH, United States, 45241
- Owner or operator
- Gentherm Medical LLC (1516825)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 13, 2010
- Registered through
- 2026
- Brand names listed
- 400CE, 414CE, FilteredFlo Warming Blankets FF-145, FilteredFlo Warming Blankets FF-243, FilteredFlo Warming Blankets FF-244, FilteredFlo Warming Blankets FF-246, FilteredFlo Warming Blankets FF-247, FilteredFlo Warming Blankets FF-248 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Temperature, Cardiopulmonary Bypass | DWC | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2023 | K232638 | FilteredFlo Warming Blankets | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| June 30, 2023 | K231596 | IOB Temperature Management System | DWJ | Substantially Equivalent | Iob Medical, Inc. | accessdata.fda.gov |
| January 17, 2013 | K123946 | WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS | DWJ | Substantially Equivalent | Cincinnati Sub-Zero Products, Inc. | accessdata.fda.gov |
| December 18, 2012 | K122813 | HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM | DWC | Substantially Equivalent | Cincinnati Sub-Zero Products, Inc. | accessdata.fda.gov |
| February 17, 2012 | K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS | DWJ | Substantially Equivalent | Cincinnati Sub-Zero Products, Inc. | accessdata.fda.gov |
| September 20, 2010 | K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS | DWJ | Substantially Equivalent | Cincinnati Sub-Zero Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 13, 2026 | 99478 | Class II | Ongoing | Blanketrol II Model 222S; Thermal regulating system. | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. | accessdata.fda.gov |
| November 22, 2021 | 89193 | Class II | Terminated | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads. | accessdata.fda.gov |
| June 17, 2021 | 88187 | Class II | Terminated | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures | There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-cooler device has the potential to aerosolize into the operating room during surg | accessdata.fda.gov |
| July 19, 2019 | 83387 | Class III | Terminated | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer. | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage | accessdata.fda.gov |
| July 2, 2019 | 83464 | Class II | Terminated | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management Model 233 - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes | accessdata.fda.gov |
| June 20, 2019 | 83376 | Class II | Terminated | Norm-O-Temp model 111Z | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage. | accessdata.fda.gov |
| December 19, 2018 | 81961 | Class II | Terminated | Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood O | Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device. | accessdata.fda.gov |
| September 4, 2018 | 80941 | Class II | Terminated | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used t | Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings. | accessdata.fda.gov |
| November 27, 2017 | 78173 | Class II | Terminated | 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 device, in conjunction | Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure. | accessdata.fda.gov |
| March 9, 2017 | 76718 | Class II | Terminated | Hemotherm CE, model 400CE, Heater-Cooling Device | Improperly rated fuses were used in the manufacture of the device. | accessdata.fda.gov |
| November 7, 2016 | 75641 | Class II | Terminated | The Hemotherm 400CE 115v, containing power board p/n 39945 | The device may not maintain water flow or temperature control. | accessdata.fda.gov |
| January 7, 2015 | 70207 | Class II | Terminated | 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 positioned on the patient. | Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak. | accessdata.fda.gov |
| January 8, 2014 | 68356 | Class II | Terminated | 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 number 86165. | The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run, however water in the reservoir will begin to return to ambient temperature. The actual | accessdata.fda.gov |
| September 3, 2013 | 66155 | Class II | Terminated | 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 maintain a desired patient | During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations & Technical (56201-Q) manuals had verbiage added back into the manual during ECN M111-4260 (released 12/29/2011) which was previously removed for clarification of the intended use and subsequent 501(K) approval. | accessdata.fda.gov |
| May 15, 2013 | 66632 | Class II | Terminated | 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, without controlling or | During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer. | accessdata.fda.gov |
| February 3, 2012 | 61754 | Not yet classified | Terminated | 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 fluid temperature. T | Design error. The probe jack contacts (terminals on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with one another. If this situation occurs, a Service Technician, Operator/User, and/or Patient could be exposed to electric shock during device s | accessdata.fda.gov |
| October 27, 2011 | 60721 | Not yet classified | Terminated | 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, in conjunction with a h | The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS or Cancer patients, were not appropriately cleared by the FDA prior to distribution. | accessdata.fda.gov |
| September 26, 2011 | 60307 | Not yet classified | Terminated | 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/monitoring device to contin | Reports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation and display a 'check probe' error. | accessdata.fda.gov |
| July 20, 2011 | 59691 | Not yet classified | Terminated | 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 Hyperthermia System is | Cincinnati Sub-Zero is conducting a field correction due to changes that have been made to the WarmAir Model 135 devices Operation and Technical Manuals in order to comply with FDA device labeling regulations. | accessdata.fda.gov |
| June 1, 2011 | 59023 | Not yet classified | Terminated | 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 convective heat transfer fro | Due to its design the circuit breaker on the device could trip causing it to shut down and not provide heated air to the blanket. | accessdata.fda.gov |
| May 19, 2011 | 59018 | Not yet classified | Terminated | 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. The device draws in | A component defect. The recalling firm determined that one of the connectors attached to the firm's WarmAir 134 device's Printed Circuit Board (PCB) can overheat. Should this event occur, the excess heat build up within the device may result in damage to the device's external case and/or melting of some of the internal components of the unit. | accessdata.fda.gov |
| May 2, 2011 | 58971 | Not yet classified | Terminated | 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 patient's blood temperature | The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use. | accessdata.fda.gov |
| October 18, 2010 | 57004 | Not yet classified | Terminated | 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 temperature and/or maintain a | The firm initiated this recall due to changes that have been made to the Blanketrol III Model 233 device's Operation and Operation/Technical Service Manuals, in order to stay in compliance with labeling regulations. | accessdata.fda.gov |
| November 14, 2009 | 53947 | Not yet classified | Terminated | FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming). | Product is labeled as "Sterile". It was observed that incomplete seals were created in the packaging materials during production. When the seal is compromised, the sterility of the product inside the package cannot be assured. | accessdata.fda.gov |
| February 16, 2009 | 51228 | Not yet classified | Terminated | 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 surgery, and other spec | The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit. | accessdata.fda.gov |
| January 18, 2005 | 30829 | Not yet classified | Terminated | Micro-temp II heat therapy unit, model #747. | There is the potential that the power switch assembly can dislodge from the cabinet during use. | accessdata.fda.gov |
| January 18, 2005 | 30820 | Not yet classified | Terminated | Electri-Cool II | There is the potential that the power switch assembly can dislodge from the cabinet during use. | accessdata.fda.gov |
| November 5, 2004 | 30414 | Not yet classified | Terminated | Warm Air Model 135 Warming Units. | Burning smell, burned microprocessor board. The firm is modifying the connectors and wiring gauge configuration of the device. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Controller, Temperature, Cardiopulmonary Bypass
Updated August 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.