Quantum Heater-Cooler
FDA 510(k) clearance K212657 · decided 2022-05-06
Clearance details
- K-number
- K212657
- Device name
- Quantum Heater-Cooler
- Applicant
- Spectrum Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-23
- Decision date
- 2022-05-06
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gloucester, GB
- 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 |
|---|---|---|
| Heater-Cooler System 3T (K220635) | Livanova Deutschland, GmbH | 2022-11-16 |
| Heater-Cooler System 3T (K191402) | Livanova Deutschland, GmbH | 2020-02-25 |
| SORIN FLEXTHERM (K140012) | Sorin Group Deutschland GmbH | 2014-01-31 |
| HEATER-COOLER UNIT HCU 40 (K130300) | Maquet Cardiopulmonary, AG | 2013-07-01 |
| HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM (K122813) | Cincinnati Sub-Zero Products, Inc. | 2012-12-18 |
| CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 (K102147) | Cardioquip Llp | 2010-11-19 |
| TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM (K071521) | Terumo Cardiovascular Systems Corp. | 2007-11-21 |
| STOCKERT HEATER-COOLER SYSTEM 3T (K052601) | Sorin Group Deutschland GmbH | 2006-06-06 |
| HEATER COOLER UNIT, MODEL HCU 30 (K031544) | Jostra AB | 2003-08-07 |
| ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER (K014016) | Minntech Corp. | 2002-02-01 |
| ORIGEN BLADDER HOLDER (K003145) | Origen Biomedical, Inc. | 2001-04-20 |
| ALPHA OMEGA DUAL COOLER-HEATER (K001520) | Alpha Omega, Inc. | 2000-11-22 |
Recalls involving this device
No recalls on record reference this clearance.