510(k) K110104 ยท DWJ System, Thermal Regulating
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
| Applicant | Cincinnati Sub-Zero Products, Inc., Sharonville OH, US |
| Decision | Substantially Equivalent, Feb 4, 2011 |
| Received | Jan 13, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110104
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Gentherm Medical, LLC Blanketrol II Model 222S; Thermal regulating system. Open, Classified |
DWJ | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.