Company
Cincinnati Sub-Zero Products LLC, a Gentherm Company
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer. Terminated |
ILO | None listed |
| Jul 2, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company CoolBlue Hyper-Hypothermia System- body hypothermia system
Model: Innercool - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. Terminated |
DWJ | K101589 |
| Jul 2, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads. Terminated |
DWJ | K110104 |
| Jul 2, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company 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/pa Terminated |
DWJ | K101589 |
| Jun 20, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp
model 111W Terminated |
DWJ | None listed |
| Jun 20, 2019 | Cincinnati Sub-Zero Products LLC, a Gentherm Company Norm-O-Temp
model 111Z Terminated |
DWJ | K120081 |
| Dec 19, 2018 | Cincinnati Sub-Zero Products LLC, a Gentherm Company 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 flow Terminated |
DWC | K122813 |
| Oct 3, 2018 | Cincinnati Sub-Zero Products LLC, a Gentherm Company 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 E Terminated |
DWC | K122813 |