The IQool System
FDA 510(k) clearance K162523 · decided 2017-05-03
Clearance details
- K-number
- K162523
- Device name
- The IQool System
- Applicant
- Braincool AB
- Decision
- Substantially Equivalent
- Date received
- 2016-09-09
- Decision date
- 2017-05-03
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- NZE
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Medicon Village, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) (K250979) | Zoll Circulation, Inc. | 2025-10-15 |
| CarbonCool® System (K240933) | Global Healthcare SG Sdn. Bhd | 2025-03-18 |
| Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (K231182) | Zoll Circulation, Inc. | 2023-11-03 |
| EMCOOLSPAD (K100071) | Emcools Emergency Medical Cooling Systems AG | 2010-10-12 |
| THERMOSUIT SYSTEM (K061023) | Life Recovery Systems Hd, LLC | 2006-09-20 |
Recalls involving this device
No recalls on record reference this clearance.