BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
FDA 510(k) clearance K101589 · decided 2010-09-20
Clearance details
- K-number
- K101589
- Device name
- BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
- Applicant
- Cincinnati Sub-Zero Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-07
- Decision date
- 2010-09-20
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DWJ
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sharonville, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Innercool Coolblue Console, Model STx; Thermal regulating system. recall (Z-2969-2026) | Gentherm Medical, LLC | 2026-08-14 |
| Blanketrol III, Model 233; Thermal regulating system. recall (Z-2970-2026) | Gentherm Medical, LLC | 2026-08-14 |
| Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road recall (Z-2209-2013) | Cincinnati Sub-Zero Products Inc | 2013-09-16 |
| 115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolB recall (Z-1817-2011) | Cincinnati Sub-Zero Products Inc | 2011-03-30 |