510(k) K101589 ยท DWJ System, Thermal Regulating
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Sep 20, 2010 |
| Received | Jun 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101589
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Gentherm Medical, LLC Innercool Coolblue Console, Model STx; Thermal regulating system. Open, Classified |
DWJ | None listed |
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol III, Model 233; Thermal regulating system. Open, Classified |
DWJ | None listed |
| 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 | 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 | 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.